Farmatex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FARMATEKS (PHARMATECH)

Composition:

Active substance: benzalkonium chloride (benzalkonium chloride);

100 g of vaginal cream contains 1.2 g of benzalkonium chloride;

Excipients: citric acid anhydrous, sodium hydrogen phosphate dodecahydrate, Tefoz® 63 (polyethylene glycol 300, polyethylene glycol 1500 and ethylene glycol stearate), lavender oil, purified water.

Pharmaceutical form. Vaginal cream.

Main physico-chemical properties: white oily cream with a lavender scent.

Pharmacotherapeutic group.

Local contraceptives. Intravaginal contraceptives.

ATC code G02BB.

Pharmacological Properties

Pharmacodynamics

Benzalkonium chloride has both spermicidal and antiseptic properties.

The active substance causes disruption of the spermatozoa membrane. Spermatozoa destruction occurs in two stages: first, the flagellum is destroyed, followed by the head.

The effectiveness of the product varies depending on how strictly the application instructions are followed.

It does not affect saprophytic microflora (Lactobacillus species, including Döderlein's rods, are preserved).

Since Pharmatex is not a hormonal drug, its use does not affect the menstrual cycle, libido, or fertility.

Experimental studies have demonstrated the antiseptic activity of benzalkonium chloride:

• In vitro, the drug is active against pathogens of sexually transmitted infections, including: Neisseria gonorrhoeae, Chlamydia spp., Herpes simplex type 2, HIV, Trichomonas vaginalis, Staphylococcus aureus. However, the product is inactive against Mycoplasma spp. and has low activity against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi, and Treponema pallidum;
• some in vivo data suggest possible effectiveness in preventing certain sexually transmitted infections, but there is no direct evidence of this preventive effect.

Pharmacokinetics

Benzalkonium chloride is practically not absorbed through the vaginal mucosa.

Clinical characteristics.

Indications.

Local contraception: this method reduces the risk of pregnancy, but does not completely exclude it, as with other contraceptive methods. The effectiveness of the spermicide depends on adherence to the instructions for medical use.

This contraceptive method is intended for all women of reproductive age. Pharmatex is particularly advisable in the following cases:

• in the presence of temporary or permanent contraindications to the use of oral contraceptives or intrauterine devices (intrauterine coil);
• after childbirth, during breastfeeding, during the premenopausal period;
• in case of need for occasional prevention of pregnancy;
• as an additional method to oral contraception in case of missed tablet intake or delayed intake (in this case, Pharmatex should be additionally used until the end of the menstrual cycle);
• as an adjunct to barrier contraception (vaginal diaphragm, cervical cap), when using an intrauterine device (especially during long-term concurrent use of certain medications, e.g. nonsteroidal anti-inflammatory drugs).

Contraindications.

This medicinal product should not be used in cases of:

• hypersensitivity to benzalkonium chloride or excipients (see section "Composition");
• use of male polyurethane condoms.

Interaction with other medicinal products and other types of interactions.

Contraindicated combinations

• Polyurethane male condoms

Risk of condom rupture.

Combinations to be avoided:

+ Medicinal products administered vaginally

Any intravaginal treatment is likely to inactivate the spermicidal effect of the local contraceptive.

+ Soaps and soap-based products

This spermicide is destroyed by soap: avoid any use of soap solutions, as even minimal amounts can inactivate the active ingredient.

Studies on compatibility between the cream and latex, conducted across various brands, showed no damage to the physical characteristics of the tested condoms.

Special precautions for use.

Pharmateks is an effective method for reducing the risk of pregnancy when used correctly during each act of sexual intercourse. However, this contraceptive method is somewhat less effective compared to other contraceptive methods such as hormonal contraception, intrauterine device, diaphragm, cervical cap, or condom.

The effectiveness of the contraceptive action greatly depends on strict adherence to the instructions for use. Therefore, it is essential to clearly explain to the patient how to use the product and to ensure that she fully understands the instructions.

This contraceptive method should be avoided in individuals who are unable to understand or follow the instructions.

Conditions to be observed when using Pharmateks:

• Systematically administer the cream deeply into the vagina before each sexual act, regardless of the phase of the menstrual cycle;
• Avoid using soap to wash the genital organs within 2 hours before and 2 hours after intercourse, as even a minimal amount of soapy water may inactivate the active ingredient. For both partners, only external washing of the genitals with clean water is permitted;
• Postpone douching with clean water for at least 2 hours to avoid the risk of washing out the preparation;
• Avoid bathing, swimming in natural water bodies, swimming pools, etc., as the contraceptive effect may be reduced;
• Discontinue use of Pharmateks if symptoms of genital tract irritation appear or worsen;
• In case of treatment with intravaginal medications, discontinue use of Pharmateks until completion of treatment. During this period, another contraceptive method should be used.

This contraceptive method does not protect against sexually transmitted infections (STIs) or against the human immunodeficiency virus (HIV) that causes acquired immunodeficiency syndrome (AIDS). When used correctly during sexual intercourse, the condom (male or female) is the only contraceptive method that additionally provides protection against STIs and HIV/AIDS.

Use during pregnancy or breastfeeding.

Clinical and epidemiological studies have not revealed any congenital malformations associated with accidental use of this product in early pregnancy.

A very small amount of the drug may pass into breast milk without any harmful effects. Breastfeeding is possible.

Ability to affect reaction rate when driving vehicles or operating machinery.

No effect on the ability to drive vehicles or operate machinery has been observed.

Dosage and Administration

Dosage

Apply systematically before each act of intercourse, regardless of the phase of the menstrual cycle.

Administration

Administer intravaginally.

In a lying position, insert one dose of vaginal cream deeply into the vagina using the applicator before intercourse.

If intercourse occurs again, insert another dose of the cream using the applicator.

The contraceptive effect begins immediately and lasts for at least 10 hours.

External genital hygiene with clean water (excluding soap-based products) is permitted immediately before and after intercourse.

Practical Advice

This contraceptive method is compatible with the use of silicone diaphragms and cervical caps, as well as male latex and polyisoprene condoms (see section "Interaction with Other Medicinal Products and Other Forms of Interaction").

Children

Do not use Farma-Tex in children.

Overdose

No cases of overdose have been reported.

Adverse reactions.

Adverse effects reported during post-marketing experience with vaginal cream Farmatex are listed below by system organ classes and frequency of occurrence using the following categories: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from the available data).

Reproductive system and breast disorders

Rare (≥1/10,000 to <1/1,000): itching, burning sensation or local irritation in one or both partners.

Immune system disorders

Frequency not known: possible allergic reactions.

Reporting suspected adverse reactions

Reporting suspected adverse reactions after authorization of the medicinal product is of great importance. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Do not use the medicinal product after the expiry date stated on the packaging!

Storage conditions.

Store at a temperature not exceeding 25 °C. Keep out of reach and sight of children.

Packaging. 72 g of cream in a tube, 1 tube with an applicator-doser in a cardboard box.

Availability category. Over-the-counter.

Manufacturer.

INNOTHERA CHOUZY, France/INNOTHERA CHOUZY, France.

Manufacturer's address and place of business.

Rue Rene Chantereau, Chouzy-sur-Cisse, Valloire-sur-Cisse, 41150, France/Rue Rene Chantereau, Chouzy-sur-Cisse, Valloire-sur-Cisse, 41150, France.

Marketing authorization holder.

LABORATOIRE INNOTECH INTERNATIONAL, France/LABORATOIRE INNOTECH INTERNATIONAL, France.

Address of the marketing authorization holder.

22 avenue Aristide Briand, 94110 Arcueil, France/22 avenue Aristide Briand, 94110 Arcueil, France.