Expiration date: 03/2025

Structure and Composition:

Vaginal capsules. 1 capsule contains:

benzalkonium chloride solution 50% aqueous solution of 37.8 mg

(Corresponds to benzalkonium chloride - 18.9 mg)

Other ingredients: hydroxypropyl cellulose silica colloidal dimethicone 1000 7-glyceryl-cocoate polyoxyethylene macrogol 400 gelatin glycerol - in the quantity required for 1 caps. vaginal

card of 2 or 6 pieces. In the paper cartons 1 or 2 blisters.

Vaginal Tablets. 1 tablet contains:

benzalkonium chloride 20 mg

Excipients: sodium bicarbonate, citric acid hydrate, anhydrous silica magnesium stearate, lactose MCC Macrogol 6000 - in the quantity required for Table 1. vaginal 0.8 g

12 pcs in a polypropylene tube. In the paper cartons 1 tube.

Vaginal Cream. 100g contains:

benzalkonium chloride solution 50% aqueous solution 2.4 g

(Corresponds to benzalkonium chloride - 1.2 g)

Excipients: citric acid dehydrated macrogol 300 and 1500 ethylene glycol stearate (Tefoz 63) sodium phosphate dibasic dodecahydrate oil lavender essence purified water

in a tube of aluminum 72 grams complete with applicator-dispenser in the paper cartons 1 set.

Vaginal Suppositories. 1 suppositorie contains:

benzalkonium chloride solution 50% aqueous solution of 37.8 mg

(Corresponds to benzalkonium chloride - 18.9 mg)

Excipients: semi-synthetic glycerides or hydroxypropylcellulose «Witepsol S51»

in blister 5 pieces. In the paper cartons 1 or 2 blisters.

Description pharmaceutical form:

Vaginal capsules: soft capsule light yellow, oval-shaped, comprising a homogeneous mass of white or white with a yellowish tinge.

Vaginal Tablets: white round tablets with a hole, and odorless.

Vaginal cream: white cream with the smell of lavender.

Vaginal Suppositories: Suppositories white cylindrical shape with a conical end, the possible presence of oil smell.

Pharmacokinetics:

Benzalkonium chloride is not absorbed vaginal mucosa. It absorbed only on the surface of the vaginal walls and then discharged with normal physiological secretions or eliminated by simple washing with water.

Description of the pharmacological actions:

Benzalkonium chloride is both spermicide and antiseptic. The active ingredient destroys the sperm membrane. The destruction of the sperm takes place in 2 stages: first, the destruction of the flagellum, then head gap that makes it impossible to fertilization.

Application Farmateksa significantly reduces the risk of pregnancy, but does not eliminate it completely.

The clinical efficacy is determined Pearl-corrected index value less than 1 if the drug is used correctly.

In vitro is active against many pathogens that cause diseases, sexually transmitted infections, particularly gonorrhea, chlamydia, herpes simplex virus (type 2) and HIV, Trichomonas vaginalis, Staphylococcus aureus.

No effect on mycoplasma and weakly acts on Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi, Treponema pallidum.

In vivo drug components are showing some activity in the prevention of certain diseases, sexually transmitted infections, but no evidence of this.

No effect on saprophytic vaginal flora, including Doderlyayna on a stick.

Indications:

Local contraception:

• for any woman of reproductive age, which has no contraindications to this
  
• in cases where there is a temporary or absolute contraindications to the use of oral contraceptives or intrauterine device (IUD)
  
• in the period after birth and during breast-feeding
  
• after abortion
  
• in the period before menopause
  
• if necessary, occasional protection against pregnancy
  
• with continuous use of oral contraceptives in the case of missing or being late in taking a tablet
  
• further using a vaginal diaphragm or IUD (especially if at the same time accepted some drugs, such as NSAIDs).
  

Contraindications:

• Hypersensitivity to the drug
  
• inability to correct application Farmateksa persons with mental disorders or those that do not allow any interference on the genitals, which prevent the use of contraceptive
  
• persons unable to understand or accept this type of contraception
  
• coleitis
  
• ulceration and irritation of the mucous membrane of the vagina and uterus.
  

Application of pregnancy and breastfeeding:

Any adverse effects associated with the drug during pregnancy was not detected - examination teratogenic properties of the final product gave negative results as well as the examination of the teratogenicity of the active substance. In addition, studies have shown that the benzalkonium chloride does not penetrate into the blood.

Because it has been proved the lack of penetration of the active substance in the blood and breast milk, the use of this spermicide during lactation does not pose any risk.

Side effect:

Allergic reactions: burning, itching, contact dermatitis.

In the case of their occurrence discontinue use of the drug.

Drug Interactions:

Do not share with any drug, applied vaginally, because they may inactivate the spermicidal action of local Farmateksa.

Pharmatex destroyed soap. Do not do vaginal irrigation before and after sexual intercourse, because the soap, even his tracks, destroying the active ingredient.

Dosage and administration:

Vaginally.

Capsules and tablets vaginal

In the "lying" position is introduced deep into the vagina, not later than 10 minutes before sexual intercourse. Duration - 4 hours (capsules) or 3 hours (tablets). Before each repeated intercourse be sure to introduce a new tablet or capsule.

A single dose - 1 tab. or 1 caps. 1 sex.

vaginal Cream

Before the introduction of the cream should be set at the end of a dosing device and tube to fill it completely (to the annular mark or the piston to the stop) so that air bubbles are not formed. Disconnect the metering device from the tube. Before intercourse enter cream deep into the vagina using a metering device, slowly pushing the plunger (introduction easier to produce lying). Remove the dispensing device. The protective effect of the drug begins immediately and continues for at least 10 hours. Before each repeated intercourse necessarily introduce a new batch of cream.

A single dose - 1 portion of cream on one sex.

vaginal Suppositories

The position of "lying" is introduced deep into the vagina at least 5 minutes prior to sexual intercourse. Duration of action -. 4 hours Be sure to enter a new suppository before each repeated intercourse.

A single dose - 1 suppository 1 intercourse.

For all dosage forms

The multiplicity of use of the drug is limited to individual tolerability and frequency of intercourse.

Perhaps the use of Farmateksa in the presence of a vaginal diaphragm or an intrauterine device.

Overdose:

Signs of overdose have not been described.

Special instructions:

Contraceptive Effectiveness associated exclusively with the strict observance of the rules of use of the drug.

• Apply regularly before each intercourse.
  
• Introducing a capsule, tablet, suppository or dispensing device with a portion of the cream so that they penetrate as deeply as possible into the vagina, preferably in position "lying".
  
• Wait for complete dissolution of capsules or tablets at least 10 minutes and suppository least 5 minutes in the vagina to the active substance has been completely released.
  
• Be sure to enter a new capsule, tablet, suppository, or cream portion before each repeated intercourse.
  
• Use soap toilet genitals 2 hours before intercourse and for 2 hours after intercourse, because soap even in residual amounts, destroys the active substance Farmateksa.
  
• Immediately after intercourse possible only external genitalia toilet with clean water or using a foaming agent Farmateks not containing soap, which includes benzalkonium chloride. Before doing vaginal irrigation, wait for 2 hours after intercourse.
  
• With farmateks introduced into the vagina, you can not take a bath, swim in the sea, swimming pools and ponds due to the risk reduction of subsequent contraceptive action.
  
• If you experience any vaginal diseases or their aggravation is necessary to interrupt the use of the drug Pharmatex (because of the content of benzalkonium chloride).
  
• If it is necessary to treat diseases of the vagina and / or the appointment of any other drug vaginally, you must wait until the end of treatment, before resuming (start) using contraception Farmateksa.