Farmatex

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

Composition:

Active substance: myristalkonium chloride;

One vaginal tablet contains 20 mg of myristalkonium chloride;

Excipients: sodium bicarbonate; anhydrous citric acid; colloidal hydrated silicon dioxide; microcrystalline cellulose; magnesium stearate; lactose monohydrate; polyethylene glycol 6000 (macrogol 6000).

Pharmaceutical form. Vaginal tablets.

Main physicochemical properties: round white tablets with a hole in the center.

Pharmacotherapeutic group.

Local contraceptives. Intravaginal contraceptives.

ATC code G02BB.

Pharmacological Properties.

Pharmacodynamics.

Myristalkonium chloride has both spermicidal and antiseptic properties.

The active substance causes disruption of the spermatozoa membrane. Destruction of spermatozoa occurs in two stages: first, the tail 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 Doderlein's bacilli, 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 myristalkonium 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 agent 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 diseases, but there are no direct clinical evidences supporting this preventive effect.

Pharmacokinetics.

Myristalkonium 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. The effectiveness of the spermicide depends on strict 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:

• when there are temporary or permanent contraindications to the use of hormonal contraception or intrauterine devices (intrauterine coil);
• after childbirth, during breastfeeding, and in the premenopausal period;
• when occasional prevention of pregnancy is needed;
• as an adjunct to oral contraception in case of missed tablet intake or delayed intake (in this case, Pharmatex should be used until the end of the menstrual cycle);
• as an adjunct to barrier contraception (see sections "Interaction with other medicinal products and other forms of interaction" and "Method of administration and dosage"), when using an intrauterine device (especially during long-term concomitant use of certain drugs, e.g., nonsteroidal anti-inflammatory agents).

Contraindications.

This medicinal product should not be used in cases of hypersensitivity to myristalkonium chloride or excipients, vaginitis, ulceration, or irritation of the vaginal and cervical mucosa.

Interaction with other medicinal products and other forms of interaction.

Combinations to be avoided:

+ Medicinal products administered vaginally

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

+ Silicone barrier contraceptives

Risk of premature deterioration of the properties of silicone-based contraceptives.

• Soaps and soap-containing products

This spermicide is inactivated by soaps—any use of soap solutions should be avoided, as even minimal amounts may destroy the active ingredient.

Special precautions for use

Pharmatex is an effective contraceptive method when used correctly prior to each sexual act. However, topical contraceptives are less effective than hormonal contraception, intrauterine devices (IUDs), diaphragms, cervical caps, or condoms.

The contraceptive efficacy of Pharmatex strongly 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 directions.

This contraceptive method should not be used by individuals unable to comprehend or follow the instructions.

Conditions to be observed when using Pharmatex:

• Insert the vaginal tablet deeply into the vagina before each sexual intercourse, regardless of the phase of the menstrual cycle;
• Avoid using soap to wash the genital area within 2 hours before and 2 hours after sexual 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 after administration to avoid washing out the drug;
• Avoid bathing, swimming in pools, natural water bodies, etc., as these may reduce the effectiveness of the contraceptive;
• Discontinue use of Pharmatex if symptoms of genital irritation appear or worsen;
• Discontinue use of Pharmatex during treatment with intravaginal medications until completion of therapy. During this period, an alternative contraceptive method should be used.

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

Use during pregnancy or breastfeeding.

Clinical and epidemiological studies have not shown any teratogenic effects 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.

Effects on the ability to drive or operate machinery.

No effects on the ability to drive vehicles or operate machinery have been observed.

Method of Administration and Dosage

Dosage

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

Method of Administration

Administer intravaginally.

Moisten the vaginal tablet with water. While lying down, insert it deeply into the vagina 10 minutes before sexual intercourse.

In case of repeated sexual intercourse, an additional tablet should be administered.

Duration of contraceptive effect – at least 3 hours.

After sexual intercourse, external genital hygiene with clean water is permitted (avoiding soap or other cleansing agents).

Do not swallow!

Practical Advice

This contraceptive method is compatible with male latex, polyisoprene, and polyurethane condoms (see section "Interaction with Other Medicinal Products and Other Forms of Interaction").

Children

Do not use Pharmatex in children.

Overdose

No cases of overdose have been reported.

Side effects

Adverse reactions reported during the post-marketing period of the medicinal product FARMATEKS, listed below by system organ classes and frequency using the following categories: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated from 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 important. 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 any suspected adverse reactions and lack of efficacy of the medicinal product 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.

No special storage conditions required. Keep out of reach and sight of children.

Packaging. 12 tablets in a polypropylene tube, in a cardboard box.

Pharmaceutical classification. Over-the-counter (without prescription).

Manufacturer.

INNOTHERA CHOUZY, France.

Manufacturer's address and place of business.

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

Marketing authorization holder.

LABORATOIRE INNOTECH INTERNATIONAL, France.

Address of the marketing authorization holder.

22 avenue Aristide Briand, 94110 Arcueil, France.