Universal reference book for medicines
Product name: PHARMATEX (PHARMATEX)

Active substance: benzalkonium chloride

Type: Vaginal contraceptive with spermicidal action

Manufacturer: Laboratoire INNOTECH INTERNATIONAL (France) manufactured by INNOTHERA CHOUZY (France)
Composition, form of production and packaging
?
Vaginal capsules are soft, translucent, light yellow in color, oval in shape; contents of capsules - emulsion from white to white with a yellowish tinge; possibly a slight stratification of the contents of the capsule.
1 caps.

benzalkonium chloride 50% aqueous solution 37.8 mg,

which corresponds to the content of benzalkonium chloride 18.9 mg

Excipients: dimethicone 1000 - 1042.2 mg, silicon dioxide colloid - 90 mg, giprolose - 105 mg, macrogol-7-glyceryl cocoate - 150 mg, macrogol 400 - 75 mg.

The composition of the shell: gelatin - 385.25 mg, glycerol - 189.75 mg.

6 pcs.
- blisters (1) - packs of cardboard.
6 pcs.
- blisters (2) - packs of cardboard.
?
The vaginal tablets are white in color, round, with a hole, odorless.
1 tab.

benzalkonium chloride 20 mg

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

12 pcs.
- polypropylene tubes (1) - cardboard packs.
?
Suppositories of vaginal white color, cylindrical, with a conical end, with a characteristic odor.
1 supp.

benzalkonium chloride 50% aqueous solution 37.8 mg,

which corresponds to the content of benzalkonium chloride 18.9 mg

Excipients: giprolose, fat solid "Witepsol S 51".

5 pieces.
- blisters (1) - cardboard boxes.
5 pieces.
- blisters (2) - cardboard boxes.
?
Vaginal cream 1.2% white, homogeneous, with the smell of lavender.
100 g

benzalkonium chloride 50% aqueous solution 2.4 g,

which corresponds to the content of benzalkonium chloride 1.2 g

Excipients: citric acid, macrogol and ethylene glycol palmitostearate (Thefos® 63), sodium hydrophosphate dodecahydrate, lavender oil, purified water.

72 g - aluminum tubes (1) complete with a dispenser - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2014.

PHARMACHOLOGIC EFFECT

Vaginal contraceptive.
Spermicidal effect due to the ability of the drug to destroy the membranes of spermatozoa (first flagella, then the heads), which leads to the impossibility of fertilization of the ovum with damaged sperm.
The effect develops 10 minutes after the introduction into the vagina.

In vitro, the preparation is active against Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Herpes simplex type 2, Staphylococcus aureus.

Weakly active against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum.

It is active against Mycoplasma spp.

It does not affect the normal microflora of the vagina (including the Doderlein stick) and the hormonal cycle.

PHARMACOKINETICS

Benzalkonium chloride is not absorbed by the mucous membrane of the vagina.
It is removed by simple washing with water and with normal physiological secretions.
INDICATIONS

Local contraception for women of reproductive age, including:

- if there are contraindications to the use of oral contraceptives or intrauterine contraception;

- in the postpartum period;

- during lactation;

- after termination of pregnancy;

- with menopause;

- with irregular sexual intercourse;

- when you miss or late in the reception of constantly used oral contraceptives.

As an additional local contraception when using a vaginal diaphragm or IUD.

DOSING MODE

Vaginal capsules.
Lying on the back, the capsule is injected deep into the vagina no later than 10 minutes before sexual intercourse. The duration of the drug is 4 hours. Be sure to enter a new capsule before each second sexual intercourse. 1 capsule is designed for one sexual act.
Tablets are vaginal.
Lying on the back, the tablet is injected deep into the vagina no later than 10 minutes before the sexual intercourse. The duration of the drug - 3 hours. Be sure to enter a new tablet before every second sexual intercourse. 1 tablet is designed for one sexual act.
Suppositories are vaginal.
Lying on the back, the suppository is injected deep into the vagina no later than 5 minutes before the sexual intercourse. Duration of the drug - 4 h. Be sure to enter a new suppository before every second sexual intercourse.
Before the introduction of a vaginal cream, you should attach the dispenser to the tube instead of the lid.
Gently squeeze the contents of the tube before filling the dispenser (until the piston stop) so that air bubbles do not form. Disconnect the dispenser from the tube. Close the tube with a lid. Lying on your back, insert the cream deep into the vagina with the help of the dispenser, slowly pressing the piston. The duration of the action is 10 hours. It is compulsory to enter a new dose of cream before every second sexual intercourse. 1 dose (5 g of cream) is designed for one sexual act.
SIDE EFFECT

Allergic reactions: contact dermatitis, itching and burning in the vagina and / or penis partner, painful urination.
If they occur, discontinue use of Pharmatex.
CONTRAINDICATIONS

- Vaginitis;

- ulceration and irritation of the mucous membrane of the vagina and cervix;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

The drug is a contraceptive, it is not used in pregnancy.
At the onset of pregnancy against the background of contraception benzalkoniya chloride influence on the course of pregnancy is not found.
Benzalkonium chloride is not excreted in breast milk, the drug can be used during lactation.

APPLICATION IN ELDERLY PATIENTS

The drug is used only in women of reproductive age.

SPECIAL INSTRUCTIONS

The effectiveness of contraception is associated exclusively with strict adherence to the rules of its use:

- administer the capsule (tablet, suppository, cream) so that the selected dosage form penetrates as deeply as possible into the vagina, preferably in the supine position;

- wait for the complete dissolution of the capsule or tablet into the vagina for at least 10 minutes, the suppository - at least 5 minutes, so that the active substance is completely released;

- always introduce a new capsule (tablet, dose of cream, suppository) before every second sexual intercourse;

- It is forbidden to use soap for the toilet of the genital organs for 2 hours before sexual intercourse and for 2 hours after sexual intercourse, tk.
soap, even in residual amounts, destroys the active substance Pharmatex;
- Immediately after sexual intercourse, the external toilet of the genital organs is possible only with clean water or with the help of the frothing agent Pharmatex, which does not contain soap, which contains benzalkonium chloride;
vaginal irrigation is carried out 2 hours after sexual intercourse;
- With Pharmatex, inserted into the vagina, you can not take baths, swim in the sea, pool and ponds because of the danger of reducing the subsequent contraceptive effect;

- Since Pharmatex contains benzalkonium chloride, it is necessary to interrupt its use in the event of any vaginal diseases or their aggravation;

- in case there is a need to treat vaginal diseases and / or the prescription of another drug vaginally, wait until the treatment is over before starting (starting) contraception with the help of Pharmatex.

Impact on the ability to drive vehicles and manage mechanisms

There is no evidence of a negative effect of the drug on the ability to drive vehicles and other mechanisms.

OVERDOSE

Cases of overdose are not marked.

DRUG INTERACTION

It is not recommended simultaneous use with drugs used vaginally.
Any drug injected into the vagina can inactivate the local spermicidal effect of Pharmatex.
Iodine solutions (including 0.1% iodonate solution) inactivate the drug.

Soap and solutions containing it can reduce the spermicidal effect of the drug.
Do not do irrigation of the vagina before and after sexual contact, because soap, even its traces, destroys the active substance.
TERMS OF RELEASE FROM PHARMACY

The drug is approved for use as a means of OTC.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 25 ° C.
Shelf life for capsules of vaginal and vaginal tablets - 2 years, for suppositories of vaginal, vaginal cream - 3 years.
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