Фарматекс
Producer: Innothera Chouzy (Innoter Shuzi) France
Code of automatic telephone exchange: G02BB
Release form: Firm dosage forms. Tablets are vaginal.
General characteristics. Structure:
Active agent:
Benzalkoniya chloride of 20,0 mg
Excipients: sodium bicarbonate, anhydrous citric acid, silicon dioxide hydrate, microcrystallic cellulose, magnesium stearate, lactose, Makrogol 6000 in the quantity necessary for one vaginal tablet weighing 0,8 g.
Description:
White round tablets with an opening, inodorous.
Pharmacological properties:
Benzalkoniya chloride is at the same time spermitsidy and an antiseptic agent. Active ingredient destroys membranes of spermatozoa. Destruction of spermatozoa happens in two stages: in the beginning destruction of a flagellum, then a rupture of a head that causes impossibility of fertilization.
Pharmateks's use considerably reduces risk of emergence of pregnancy, however does not eliminate it completely.
Clinical performance is defined by the adjusted index of Perl which makes less than 1 if drug is correctly used.
In vitro drug is effective concerning many activators causing diseases, sexually transmitted, especially a gonokokka, chlamydias, a herpes virus type 2, a human immunodeficiency virus, a vulval trichomonad, golden staphylococcus. Drug has no effect on mycoplasmas and poorly acts on Gardnerella vaginalis, Candida albicans, Haemophilus ducrey and Treponema pallidum.
In vivo components of drug show some activity in the prevention of some diseases, sexually transmitted, however proofs to it are not available. Drug does not influence saprophytic vulval microflora, including Doderlyayn's stick.
Pharmacokinetics. Benzalkoniya chloride is not soaked up by a mucous membrane of a vagina. It is absorbed only on a surface of walls of a vagina and then removed with normal physiological allocations or is eliminated with simple washing with water.
Indications to use:
Local contraception for any woman of reproductive age who does not have to it contraindications and also in cases:
- existence of temporary or absolute contraindications to use of oral contraceptives or an intrauterine spiral (Naval Forces);
- during the period after the delivery and during feeding by a breast;
- after abortion;
- during the period preceding a menopause;
- in need of incidental protection from pregnancy;
- at constant use of oral contraceptives in case of the admission or delay in reception of a tablet.
As additional local contraception when using a vaginal diaphragm or intrauterine spiral (especially if in the same time some drugs, such as non-steroidal anti-inflammatory drugs are accepted).
Route of administration and doses:
To enter into a vagina.
In a prone position the tablet is entered deeply into a vagina not later than 10 minutes before sexual intercourse. Duration of effect of drug - 3 hours. It is obligatory to enter a new tablet before each repeated sexual intercourse.
Single dose: one tablet is counted on one sexual intercourse. Frequency rate of use is limited to individual subjective portability of active ingredient and frequency of sexual intercourses.
Pharmateks's use together with a vulval diaphragm or Naval Forces is possible.
Features of use:
Efficiency of contraception is connected only with strict observance of rules of its use.
• To apply systematically before each sexual intercourse.
• To enter a tablet so that it as it is possible more deeply got into a vagina, it is preferable in a prone position
• To wait for full dissolution of a tablet in a vagina within not less than 10 minutes that active ingredient was completely released.
• It is obligatory to enter a new tablet before each repeated sexual intercourse.
• Use of soap for a toilet of generative organs in 2 hours prior to sexual intercourse and within 2 hours after sexual intercourse since soap, even in residual quantities, destroys active ingredient of Pharmateks is forbidden.
• Right after sexual intercourse only the outside toilet of generative organs only clear water or by means of the foaming means of Pharmateks which is not containing soap which part chloride a benzalkoniya is is possible. Before doing vulval irrigation, it is necessary to wait within 2 hours after sexual intercourse.
• With Pharmateks entered into a vagina it is impossible to take baths, to swim in the sea, the pool and reservoirs because of danger of decrease in the subsequent contraceptive action.
• As Pharmateks the benzalkoniya contains chloride it is necessary to interrupt its use when developing any diseases of a vagina or their aggravation.
If there is a need of treatment of diseases of a vagina and/or purpose of any other medicine intravaginalno, it is necessary to wait for the end of treatment before to renew (to begin) contraception by means of Pharmateks.
Use during pregnancy and feeding by a breast:
Any harmful effects connected with use of drug during pregnancy it was revealed not: examination of teratogenic properties of an end product yielded negative takes as well as examination of teratogenic properties of the most active ingredient. Besides, researches showed that the benzalkoniya chloride does not get into blood. Feeding by a breast: as lack of penetration of active ingredient into blood and maternal milk, use of this spermitsid during feeding was proved by a breast does not constitute any danger.
Side effects:
Allergic reactions to drug components (burning, itch), contact dermatitis. In case of their emergence to stop Pharmateks's use.
Interaction with other medicines:
Simultaneous use with the medicines used vaginalno is not recommended. Any medicine entered into a vagina can inactivate local spermicidal action of Pharmateks.
Фарматекс collapses soap. It is not necessary to do irrigations of a vagina before sexual contact because soap, even its traces, destroys active ingredient.
Contraindications:
- impossibility of the correct use of Pharmateks for persons with disturbances of mentality or the persons which are not allowing any interventions on generative organs which interfere with use of a contraceptive;
- to any person not capable to understand or agree with this type of contraception;
- hypersensitivity to drug components;
- colpitis;
- ulceration and irritation of a mucous membrane of a vagina and uterus.
Overdose:
Signs of overdose are not described.
Storage conditions:
To store at a temperature not above 25 °C. List B. To store in the place not available to children. Period of validity: 2 years. Not to apply after the period of validity specified on packaging.
Issue conditions:
Without recipe
Packaging:
On 12 tablets vaginal in a polypropylene tuba, closed by the stopper from polyethylene supplied with silica gel. 1 tuba together with the application instruction is placed in a cardboard pack.