Farmateks® (Miristalkonii Chloridum) 20 mg, 12 tablets
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Instruction for medical use of PHARMATEKS® medicine Trade name of Farmateks® International unlicensed name Miristalkoniya chloride Dosage form of the Tablet vaginal Structure active agent: miristalkoniya chloride of 20.0 mg excipients: Natrii hydrocarbonas, anhydrous citric acid, silicon dioxide colloidal anhydrous, magnesium stearate, cellulose microcrystalline, lactoses monohydrate, a macrogoal 6000 Description Round white tablets with an opening in the center Pharmacotherapeutic group Other drugs for treatment of gynecologic diseases. Contraceptives for topical administration. Intravaginalny contraceptives. The ATX G02BB code the Pharmacological Miristalkoniya’s Pharmacokinetics properties 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 discharges or is eliminated with simple washing with water. Miristalkoniya’s pharmacodynamics 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. The efficiency of a method depends on correctness and the accuracy of observance of recommendations about use. Saprophytic flora under the influence of a contraceptive does not change – Farmateks® does not affect quantity of lactobacilli (Doderlyayn’s sticks). Without being hormonal drug, Farmateks® does not influence a menstrual cycle, a libido, fertility. Miristalkoniya chloride also shows antiseptic activity: · in vitro, drug is active concerning causative agents of infections, sexually transmitted, namely: Neisseria gonorrhoeae, Chlamydia spp., Herpes simplex type 2, HIV, Trichomonas vaginalis, Staphylococcus aureus. Nevertheless, it is not active concerning Mycoplasma spp. also Candida albicans, Haemophilus ducreyi and Treponema pallidum is low active concerning Gardnerella vaginalis, · in vivo, some elements are active concerning causative agents of some diseases, sexually transmitted. Information on use as prophylactic is absent. Indications Local contraception for any woman of reproductive age who does not have to it contraindications and also in cases: – in the presence of temporary or absolute contraindications to use of hormonal contraceptives or an intrauterine spiral (Naval Forces) – during the period after the delivery and during feeding by a breast – during the period preceding a menopause – in need of incidental protection from pregnancy – as additional local contraception when using a vaginal diaphragm, cervical cap or intrauterine spiral (especially at prolonged use of medicines such as non-steroidal anti-inflammatory drugs). – as an additional method of contraception at the admission or delay in reception of oral hormonal contraceptives. In this case it is recommended to combine both methods of contraception throughout the remained days of a menstrual cycle. A route of administration and doses For vaginal use. In a dorsal decubitus, the tablet moistened with water 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. The frequency rate of use is limited to individual subjective tolerance of active ingredient and frequency of sexual intercourses. use of a pharmatex together with a vaginal diaphragm or Naval Forces is possible. Right after sexual intercourse only the toilet of external genitals plain water is admissible. Side effects – Allergic reactions, contact dermatitis, an itching and burning at one or both partners. In case of their emergence to stop Pharmatex’s use. Contraindications – hypersensitivity to drug components – a colpitis, a vaginitis – an ulceration and irritation of a mucous membrane of a vagina and uterus – impossibility of the correct use of Pharmatex for persons with disturbances of mentality or the persons which are not allowing any interventions on genitals which interfere with use of a contraceptive – any person not capable to understand or agree with this type of contraception. Medicinal interactions Any means entered into a vagina can inactivate local spermicidal action of Pharmatex. Active ingredient – a miristalkoniya chloride, collapses soap therefore use of soap for a toilet of genitals, even in the minimum quantities is forbidden. The special instructions Farmateks® is effective drug for protection from pregnancy on condition of its correct use. However, the method of spermicidal local contraception is always less effective, in comparison with hormonal contraception, intrauterine contraceptives, a diaphragm, a cervical cap or condom. The efficiency of contraception is connected only with strict observance of rules of its use. · To apply systematically before each sexual intercourse. · Use of soap for a toilet of genitals for both partners in 2 hours prior to sexual intercourse and within 2 hours after sexual intercourse since soap, even in residual quantities, destroys Pharmateksa active ingredient is forbidden. · Right after sexual intercourse only the external toilet of genitals only plain water is possible. Before doing vaginal irrigation, it is necessary to wait within 2 hours after sexual intercourse. · With Pharmatex, entered into a vagina, it is impossible to take baths, to swim in the sea, the pool and reservoirs in order to avoid decrease in its contraceptive action. · In case there is a need of treatment of diseases of a vagina and/or prescribing of any other medicine vaginalno, it is necessary to wait for the end of treatment before renewing (to begin) contraception by means of Pharmatex. · This method of contraception does not protect from infections, sexually transmitted or caused by a human immunodeficiency virus. From these diseases there is only one method of barrier contraception – condom. Pregnancy and the period of a lactation of Any harmful effects connected with use of drug during pregnancy it was revealed not: examination of teratogenic properties of the final product yielded negative takes as well as examination of teratogenic properties of the most active ingredient. Penetration into maternal milk is possible in extremely insignificant quantity without any known negative consequences. Drug can be used during breastfeeding. The feature of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms does not influence. The overdose is not revealed the Form of release and packing On 12 tablets place in tubas pilipropilenovy, closed by a stopper from polyethylene with silica gel. On 1 tuba together with the instruction for medical use in the state and Russian languages place Storage conditions in a cardboard pack to Store at a temperature not above 30 °C. To store out of children’s reach! 3 years not to use a period of storage after the expiration date specified on packing. Prescription status Without prescription the Producer Innotera Shuzi, Rue Rene Shantero, Shuzi-Sur-Cis, 41150 Valuar-sur-Cis, France the Stradis Organization packer, France the Owner of the registration certificate Innotek Internasional Laboratory, France the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products (goods) responsible for post-registration observation of safety of medicine Representation Innotek Internasional Laboratory of S.A.S. in RK 050059, Republic of Kazakhstan, Almaty, Al-Farabi Ave., 17, business center of Nurla Tau, the block of 4 B, office 606, bodies./ fax: +7-727-311-09-71, +7-727-311-09-72, e-mail: firstname.lastname@example.org
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