PHARMATEX

Active material: benzalkonium chloride
When ATH: G02BB
CCF: Vaginal contraceptive device with spermicidnym effect
ICD-10 codes (testimony): Z30.0
When CSF: 23.14.02
Manufacturer: Laboratoire INNOTECH INTERNATIONAL (France)

DOSAGE FORM, COMPOSITION AND PACKAGING

Vaginal capsules Soft, light yellow, Oval; contents of capsules – homogeneous mass of white or white with a yellowish Sheen color.

1 caps.
benzalkonium chloride 50% water solution37.8 mg,
incl. benzalkonium chloride18.9 mg

Excipients: hydroksypropyltsellyuloza, colloidal silicon dioxide, Dimethicone 1000, 7-glicerilkokoat polioksiètilenglikolâ, macrogol 400, gelatin, glycerol.

2 PC. – blisters (1) – cardboard boxes.
2 PC. – blisters (2) – cardboard boxes.
6 PC. – blisters (1) – cardboard boxes.
6 PC. – blisters (2) – cardboard boxes.

Vaginal Tablets white, with a hole, without smell.

1 tab.
benzalkonium chloride20 mg

Excipients: sodium bicarbonate, Citric acid anhydrous, silicon dioxide hydrate, microcrystalline cellulose, magnesium stearate, lactose, macrogol 6000.

12 PC. – polypropylene tubes (1) – packs cardboard.

Vaginal Suppositories white, cylindrical, with the cone-shaped end of the, Perhaps the presence of odor of fat.

1 supp.
benzalkonium chloride 50% water solution37.8 mg,
incl. benzalkonium chloride18.9 mg

Excipients: hydroksypropyltsellyuloza, semi-synthetic or glycerides “Witepsol S 51”.

5 PC. – blisters (1) – cardboard boxes.
5 PC. – blisters (2) – cardboard boxes.

Vaginal Cream 1.2% white, with the smell of lavender.

100 g
benzalkonium chloride 50% water solution2.4 g,
incl. benzalkonium chloride1.2 g

Excipients: lemon acid, macrogol 300 and makrogola 1500 and ethylene glycol stearate (Tefoz 63), Lavender essence oil, Purified water.

72 g – aluminum tuba (1) complete with dispenser – packs cardboard.

 

Pharmacological action

Vaginal contraceptive. Benzalconia chloride is simultaneously a spermicide and antiseptic. Active substance destroys sperm membrane. Destruction of spermatozoa occurs in two stages: in the beginning the destruction of the flagellum, then the gap head, that makes it impossible to fertilization.

Use significantly reduces the risk of Farmatexa pregnancy, but does not eliminate it entirely.

Clinical effectiveness is determined by the Pearl Index korrektirovannym, that is less than 1 in that case, If the product is properly used.

In vitro drug active against Many pathogens, causing diseases, Sexually Transmitted Infections, особенно Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Staphylococcus aureus, Herpes simplex тип 2, HIV.

Preparation are not active against Mycoplasma spp. and weakly active against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi и Treponema pallidum.

In vivo drug components are showing some activity in the prevention of diseases, sexually transmitted, However, this evidence is not available.

The drug does not affect saprophyte bacterial vaginal microflora, incl. on a stick Doderlâjna.

 

Pharmacokinetics

Benzalconia chloride is not absorbed mucous membrane vagina. Absorbed only on the surface of the walls of the vagina and then return to normal physiological droppings or eliminates simple washing with water.

 

INDICATIONS

Local contraception for any woman of reproductive age, not relevant to the contraindications, and in cases:

— availability of interim or absolute contraindications to the use of oral contraceptives or intrauterine device;

-in the period after birth and during breast-feeding;

-after abortion;

-in period, predšestvuûŝij menopause;

-If necessary, episodic contraception;

- At constant use of oral contraceptives in the case of missing or being late in taking the pill.

As an additional local contraception using vaginal diaphragm or an intrauterine device (especially, if at the same time accepted some drugs, such as NSAIDs).

 

DOSAGE

Vaginal capsules. Lying on his back, capsule injected deep into the vagina at the latest, than 10 minutes before sexual intercourse. The duration of drug action – 4 no. Be sure to enter a new capsule before each repeated intercourse. 1 the capsule is designed for a single sexual act.

Vaginal Tablets. Lying on his back, tablet is introduced deep into the vagina at the latest, than 10 minutes before sexual intercourse. The duration of drug action – 3 no. Be sure to introduce a new tablet before each repeated intercourse. 1 a tablet designed for a sexual act.

Vaginal Suppositories. Lying on his back, suppository injected deep into the vagina at the latest, than 5 minutes before sexual intercourse. The duration of drug action – 4 no. Be sure to enter a new suppository before each repeated intercourse. 1 suppository is a one sexual act.

Before administration vaginal cream the dispensing device should be installed at the end of the tube. Fill it completely (to the annular mark or the stop piston) So, so that no air bubbles. Disconnect the device from the metering tube. Before intercourse cream enter deeply into the vagina using a metering device, slowly pushing the plunger. Remove the metering device. Introduction easier to produce lying. The protective effect begins immediately and continues for at least 10 no. Be sure to enter a new batch of cream for each repeated intercourse. 1 serving of cream intended for one sex act.

The multiplicity of use of the drug is limited to individual tolerability of the active substance and the frequency of sexual acts.

Can be used in conjunction with Farmateksa vaginal diaphragm or IUD.

 

SIDE EFFECT

Allergic reactions: burning, itch, contact dermatitis (in the case of their occurrence discontinue use Farmateksa).

 

CONTRAINDICATIONS

- The inability to properly use Farmateksa persons with mental disorders and persons, do not allow any interference on the genitals, and to prevent the use of contraceptive;

- Any person, I can not understand or agree with this kind of contraception;

- Colpitis;

- Ulceration and irritation of the vagina and uterus;

- Hypersensitivity to the drug.

 

Pregnancy and lactation

Any harmful effects, associated with the drug during pregnancy, It was found. Examination of teratogenic properties of the final product gave negative results, as well as examination of teratogenic properties of the active substance. Besides, studies showed, benzalkonium chloride that is not absorbed into the blood.

Since it was proved the absence of penetration of the active substance in the blood and breast milk, Use of this spermicide during breastfeeding poses no danger.

 

Cautions

Effective contraception is associated exclusively with the strict observance of the rules of use:

- To apply systematically before each sexual act;

- To enter the capsule (tablet, suppozytoryy, cream) So, that the selected dosage form as deeply penetrated into the vagina, preferably in the supine position;

- To wait for complete dissolution of capsules or tablets in the vagina for at least 10 minutes, suppository - at least 5 m, to the active substance has been completely released;

- Be sure to introduce a new capsule (tablet, dose cream, suppozytoryy) before each repeated intercourse;

- Do not use soap for the toilet of genitals 2 hours before sexual intercourse and during 2 hours after intercourse, tk. soap, even in residual amounts, destroys the active substance Farmateksa;

- Immediately after intercourse can only outdoor toilet genitals only clean water or by using a foaming agent Pharmatex, not containing soap, which includes benzalkonium chloride. Before making a vaginal irrigation, should wait for 2 hours after intercourse;

- With farmateks, inserted into the vagina, you can not take a bath, swim in the sea, swimming pools and ponds because of the danger of subsequent reduction of the contraceptive effect;

- Because Pharmatex contains benzalkonium chloride, to interrupt its use in case of any disease or aggravation of the vagina;

- when, if there is a need to treat diseases of the vagina and / or destination of any other drug vaginally, you must wait until the end of treatment before, than to renew (start) using contraception Farmateksa.

 

OVERDOSE

Due to the low systemic absorption overdose is unlikely.

At the moment the symptoms are not described overdose.

 

Drug Interactions

Not recommended simultaneous application with the drugs, applied vaginally. Any drug, introduced into the vagina, can inactivate the local spermicidal action Farmateksa.

Pharmatex destroyed soap. Do not make the irrigation of the vagina before and after sexual intercourse, because soap, even his tracks, It destroys the active substance.

 

Conditions of supply of pharmacies

The drug is resolved to application as an agent Valium holidays.

 

TERMS AND CONDITIONS OF STORAGE

List B. The drug should be stored out of reach of children at or above 25 ° C. Shelf life for vaginal capsules, vaginal tablets, and - 2 year, vaginal suppository, vaginal cream - 3 year.