Фарматекс
Producer: Innothera Chouzy (Innoter Shuzi) France
Code of automatic telephone exchange: G02BB
Release form: Firm dosage forms. Suppositories vaginal.
General characteristics. Structure:
Active ingredient: Benzalkoniya chloride of 50% aqueous solution of 37,8 mg that corresponds a benzalkoniya to chloride of 18,9 mg;
Excipients: Hypro rod of 9,1 mg; fat firm Witepsol S 51 1553,1 of mg;
Description: suppositories of white color, a cylindrical form with the cone-shaped end, with a characteristic smell.
Pharmacological properties:
Pharmacodynamics. Spermicidal action is caused by ability of active ingredient to destroy membranes of spermatozoa (at first flagellums, then heads) that results in impossibility of fertilization of an ovum the damaged spermatozoon. The effect develops in 5 min. after introduction to a vagina.
In vitro: it is active concerning Neisseria gonorrhoeae., Chlamydia spp., Trichomonas vaginalis., Herpes simplex type 2, Staphylococcus aureus. Has no effect on Mycoplasma spp. and poorly affects Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum.
Also the hormonal cycle does not influence normal microflora of a vagina (including Doderlyayn's stick).
Pharmacokinetics. Benzalkoniya chloride is not soaked up by a mucous membrane of a vagina, leaves simple washing by water and with normal physiological allocations.
Indications to use:
Local contraception for women of reproductive age (including in the presence of contraindications to use of oral contraceptives or intrauterine contraception; in a puerperal period, a lactation; after abortion; at a menopause; irregular sexual contacts; the admission or delay in reception of constantly used oral contraceptives).
As additional local contraception when using a vaginal diaphragm or intrauterine spiral.
Route of administration and doses:
For vaginal use.
Lying on spin, suppository is entered deeply into a vagina in 5 minutes prior to sexual intercourse. Action duration - 4 hours. It is obligatory to enter new suppository before each repeated sexual intercourse.
Features of use:
Efficiency of contraception depends on the correct use of drug.
• Use of soap for a toilet of generative organs in 2 hours prior to and 2 hours after sexual intercourse since soap destroys active ingredient of Pharmateks is forbidden.
• After sexual intercourse the toilet of external genitals only clear water is possible. Vulval irrigation is applied in 2 hours after sexual intercourse.
• With Pharmateks entered into a vagina because of danger of decrease in the subsequent contraceptive action it is impossible to take baths and to swim in the sea, the pool and reservoirs.
• It is necessary to stop temporarily Pharmateks's use at vagina diseases before the end of treatment of vaginal medicines.
Influence on ability to manage vehicles
There are no data on negative influence of drug on ability to manage vehicles and other mechanisms.
Side effects:
Allergic reactions, contact dermatitis, itch and burning in a vagina and/or a penis of the partner, an urodynia.
In case of their emergence to stop Pharmateks's use.
If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.
Interaction with other medicines:
Any medicine, and also the soap and solutions containing it can reduce spermicidal effect of drug. Iodine solutions (including 0,1% Iodonatum solution) inactivate drug.
Contraindications:
Hypersensitivity to drug components, a vaginitis, an ulceration and irritation of a mucous membrane of a vagina and neck of uterus.
Pregnancy and period of a lactation
Drug is a contraceptive, during pregnancy is not used.
At approach of pregnancy against the background of contraception a benzalkoniya chloride, impact on the course of pregnancy is not revealed. It is not allocated with breast milk, it can be applied in the period of a lactation.
Overdose:
Cases of overdose are noted.
Storage conditions:
To store at a temperature not above 25 °C. To store in the place, unavailable to children.
If from heat suppositories melt, it is necessary to put them in the refrigerator or to place under a stream of cold water the pointed end down - suppositories will take the initial form; the composition of drug at the same time will not change. Period of validity 3 years. Not to use after the period of validity specified on packaging.
Issue conditions:
Without recipe
Packaging:
Suppositories vaginal.
On 5 suppositories in a strip from PVC of the film covered with polyethylene of low density. 1 or 2 strips with the application instruction in a cardboard pack.