Pharmatex, cream, 72g

Composition

Composition per 100 g of cream

Active ingredient:

Benzalkonium chloride 50% water solution – 2.4 g,

which corresponds to benzalkonium chloride-1.2 g

Auxiliary substances:

citric acid-0.002 g

disodium hydrophosphate dodecahydrate-up to pH 3.5-5.5

macrogol and ethylene glycol

palmitostearate (Tephoz ® 63) – 24.0 g

lavender oil-0.05 g

purified water – up to 100 g

Pharmacological action

A topical contraceptive.

ATX code: G02BB

Pharmacological properties

Pharmacodynamics

Benzalkonium chloride is both a spermicide and an antiseptic. Spermicidal action is due to the ability of the Active ingredient to destroy the membranes of spermatozoa (first flagella, then heads), which leads to the impossibility of fertilization of the egg with damaged sperm. The effect develops immediately after the introduction of the cream into the vagina.

The use of Pharmatex significantly reduces the risk of pregnancy, but does not eliminate it completely.

It does not affect the normal microflora of the vagina (including Doderlein’s wand).

Pharmatex does not affect the menstrual cycle, libido and fertility.

In vitro benzalkonium chloride is active against Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Herpes simplex type 2, Staphylococcus aureus. It has no effect on Mycoplasma spp. and it has a weak effect on Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum.

Pharmacokinetics

The absorption of benzalkonium chloride by the vaginal mucosa is very low. From the surface of the mucous membrane, the drug is removed by simple washing with water and with normal physiological secretions.

Indications

Local contraception for women of reproductive age, and especially:

– in the presence of contraindications to the use of hormonal contraceptives or intrauterine contraception;

in the postpartum period, the period of breastfeeding; after the termination of pregnancy;

– with premenopausal women; at irregular sexual contact;

as additional contraception when using a vaginal diaphragm, cervical cap or other intrauterine contraceptives, especially with prolonged use of medications such as NSAIDs (non-steroidal anti-inflammatory drugs).

– as an additional method of contraception if you miss or are late in taking oral hormonal contraceptives. In this case, it is recommended to combine both methods of contraception during the remaining days of the menstrual cycle.

Use during pregnancy and lactation

Pregnancy

The drug is a contraceptive and is not used during pregnancy.

Accidental use of this spermicide in the early stages of pregnancy did not reveal any negative effects on the fetus. Breast-feeding

Penetration into mother’s milk is possible in extremely small amounts without any known negative consequences. The drug can be used during breastfeeding.

Contraindications

Hypersensitivity to the components of the drug, vaginitis, ulceration and irritation of the mucous membrane of the vagina and cervix.

Side effects

Allergic reactions, contact dermatitis, itching and burning in the partner’s vagina and / or penis, painful urination.

If they occur, stop using Pharmatex.

If any of the side effects listed in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction

Any agent used intravaginally can reduce the spermicidal effect of the drug. The Active ingredient-benzalkonium chloride, is destroyed by soap, so it is forbidden to use soap for the toilet of the genitals, even in minimal quantities.

How to take, course of use and dosage

For vaginal use.

Attach the dispenser to the tube instead of the cap. Gently squeeze out the contents of the tube until the dispenser is full (until the piston stops) so that no air bubbles form. Disconnect the dispenser from the tube. Close the tube with a lid.

Lying on your back, insert the cream deep into the vagina using the dispenser, slowly pressing the plunger. Duration of action – 10 hours. Be sure to enter a new dose of cream before each repeated sexual intercourse.

One dose (5 g of cream) is designed for one sexual act.

Overdose

No cases of overdose have been reported.

Description

White homogeneous cream with the smell of lavender.

Special instructions

Pharmatex is an effective drug for preventing pregnancy, provided that it is used correctly. However, spermicidal local contraception is always less effective than hormonal contraception, intrauterine contraceptives, a diaphragm, a cervical cap, or a condom.

It is forbidden to use soap for the toilet of the genitals 2 hours before and 2 hours after sexual intercourse, because soap destroys the Active ingredient of the drug Pharmatex.

Toilet of the external genitals is possible only with plain water for both partners. Vaginal irrigation (douching) can be applied no earlier than 2 hours after sexual intercourse.

With the drug Pharmatex inserted into the vagina, you can not take baths and swim in the sea, pool and reservoirs in order to avoid reducing its contraceptive effect.

If treatment with drugs for vaginal use is necessary, the use of Pharmatex should be temporarily discontinued until the end of the course of treatment.

This method of contraception does not protect against sexually transmitted infections or those caused by the human immunodeficiency virus. From these diseases, there is only one method of barrier contraception – a condom.

Impact on the ability to drive vehicles

There are no data on the negative effect of the drug on the ability to drive vehicles and other mechanisms.

Form of production

Vaginal cream 1.2%.

72 g of cream in an aluminum tube with a membrane and a screw cap made of high-density polyethylene with a perforator for piercing the membrane. The tube inside is covered with a protective epoxy-phenolic varnish. One tube with instructions for use and a dispenser made of low-density polyethylene in a cardboard pack.

Storage conditions

Store at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf

life is 3 years. Do not use after the expiration date.

Active ingredient

Benzalkonium chloride

Dosage form

cream

Description

For women of childbearing age

Indications

For contraception