Active substanceBenzalkonium chlorideBenzalkonium chloride
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  • Dosage form: & nbspVaginal capsules.
    Composition:

    Active substance:

    Benzalkonium chloride 50 % aqueous solution ................. 37.8 mg,

    which corresponds to benzalkonium chloride ... 18.9 mg

    Excipients:

    dimethicone 1000 ............................................... 1042, 2 mg

    silicon dioxide colloidal .......................... 90.0 mg

    giprolose ................................................. ......... 105.0 mg

    Macrogol-7-glyceryl cocoate 150.0 mg

    macrogol 400 ................................................ 75.0 mg

    Shell composition:

    gelatin .................................. '........... 385.25 mg

    glycerol ............................................. 189.75 mg

    Description:

    Soft translucent capsules of light yellow color, oval in shape. The contents of the capsules are an emulsion from white to white with a yellowish tinge. Perhaps a slight stratification of the contents of the capsule.

    Pharmacotherapeutic group:Contraceptive agent for topical application.
    ATX: & nbsp

    D.08.A.J.01   Benzalkonium chloride

    G.02.B.B   Intravaginal contraceptives

    Pharmacodynamics:

    Spermicidal action is due to the ability of the active substance to destroy the membranes of spermatozoa (first flagella, then the heads), which leads to the impossibility of fertilization of the egg cell with damaged sperm. The effect develops 5 minutes after the introduction into the vagina.

    The effect develops 10 minutes after the introduction into the vagina.

    In vitro is active against Neisseria gonorrhoeae., Chlamydia spp., Trichomonas vaginalis., Herpes simplex type 2, Staphylococcus aureus.It does not affect Mycoplasma spp. and weakly affects Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum.

    It does not affect the normal microflora of the vagina (including Doderylein's stick) and the hormonal cycle.

    Pharmacokinetics:Benzalkonium chloride is not absorbed by the mucous membrane of the vagina, it is removed by simple washing with water and with normal physiological excretions.
    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 termination of pregnancy; with menopause; irregular sexual intercourse; miss or late in the reception of ever-used oral contraceptives.

    As an additional local contraception when using vaginal diaphragm or intrauterine device.

    Contraindications:

    Hypersensitivity to the drug components, vaginitis, 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. It is not excreted in breast milk, it can be used during lactation.
    Dosing and Administration:For vaginal application.
    Lying on the back, the capsule is injected deep into the vagina 10 minutes before the sexual intercourse. The duration of the action is 4 hours. Be sure to enter a new capsule before each second sexual intercourse.
    Side effects:

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

    If they occur, discontinue use of Pharmatex.

    If any of the above, the side effects are aggravated, or you notice any other side effects not listed in the instructions, report this doctor.

    Overdose:Cases of overdose are not marked.
    Interaction:Any medicine, as well as soap and solutions containing it, can reduce the spermicidal effect of the drug. Iodine solutions (including 0.1% solution, iodonate) inactivate the drug.
    Special instructions:

    The effectiveness of contraception depends on the correct use of the drug.

    - It is forbidden to use soap for the toilet of the genitals 2 hours before and after sexual intercourse, tk. soap destroys the active substance Pharmatex.

    - After sexual intercourse, the toilet of the external genital organs is only clean water. Vaginal irrigation is used 2 hours after sexual intercourse.

    - With Pharmatex injected into the vagina, because of the danger of decreasing the subsequent contraceptive effect, you can not take a bath and swim in the sea, pool and water reservoirs.

    - It is necessary to temporarily stop the use of Pharmatex for vaginal diseases before end of treatment with vaginal drugs.

    Effect on the ability to drive transp. cf. and fur:

    There is no evidence of a negative effect of the drug on the ability to manage vehicles and other mechanisms.

    Form release / dosage:Vaginal capsules are 18.9 mg.
    Packaging:
    For 6 capsules in PVC / aluminum blister.
    1 or 2 blisters with instructions for use in a cardboard bundle.
    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.
    Shelf life:

    2 years. Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N011489 / 05
    Date of registration:14.05.2009
    The owner of the registration certificate:Laboratory Innotech InternationalLaboratory Innotech International France
    Manufacturer: & nbsp
    Representation: & nbspLaboratory Innotech International Laboratory Innotech International France
    Information update date: & nbsp18.05.2012
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