Farmatex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FARMATEX (PHARMATEX)

Composition:

Active substance: benzalkonium chloride;

1 vaginal suppository (1.6 g) contains benzalkonium chloride 18.9 mg;

Excipients: hydroxypropylcellulose, semi-synthetic glyceride solid (type Witepsol S 51).

Pharmaceutical form. Vaginal suppositories.

Main physicochemical properties: white, cylindrical-shaped suppositories with a conical tip.

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. Destruction of spermatozoa 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 preparation is active against pathogens transmitted through sexual contact, 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; however, there are no direct proofs of this preventive effect.

Pharmacokinetics.

Benzalkonium chloride is practically not absorbed by 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 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:

• in the presence of temporary or permanent contraindications to the use of oral contraceptives or intrauterine devices (intrauterine coil);
• after childbirth, during breastfeeding, and during the premenopausal period;
• in case of need for occasional prevention of pregnancy;
• as an auxiliary method to oral contraception in case of missed tablet intake or delayed intake (in this case, Pharmatex must be additionally used until the end of the menstrual cycle);
• as an auxiliary agent with barrier contraception (vaginal diaphragm, cervical cap), or when using an intrauterine coil (especially during prolonged simultaneous use of certain drugs, e.g., non-steroidal anti-inflammatory agents).

Contraindications.

This medicinal product should not be used in cases of:

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

Interaction with other medicinal products and other forms of interaction.

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 detergent products

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

A compatibility study between the vaginal suppository and latex, performed with various commercial brands, revealed no changes in the physical characteristics of the tested condoms.

Special precautions for use.

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

The effectiveness of the contraceptive action significantly 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 she fully understands all instructions.

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

Conditions to be observed when using Pharmatex:

• Insert the suppository deeply into the vagina systematically 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 intercourse, as even a minimal amount of soap can destroy 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 product;
• Avoid taking baths, swimming in open water, pools, etc., as the contraceptive effect may be reduced;
• Discontinue use of Pharmatex if symptoms of genital tract irritation appear or worsen;
• In case of treatment with intravaginal medications, discontinue use of Pharmatex until the end of treatment. During this period, an alternative contraceptive method should be used.

This contraceptive method does not protect against sexually transmitted infections (STIs) or 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 developmental abnormalities 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 influence reaction speed when driving or operating machinery.

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

Method of Administration and Dosage.

Dosage

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

Method of Administration

Administer intravaginally.

In a lying position, insert 1 vaginal suppository deeply into the vagina 5 minutes before sexual intercourse.

In case of repeated intercourse, administer another suppository.

Duration of contraceptive effect — 4 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.

Farmatex should not be used in children.

Overdose.

No cases of overdose have been reported.

Adverse Reactions

Adverse effects reported during post-marketing experience with FarmaTex vaginal suppositories 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 (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), frequency not known (cannot be estimated based on 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 of suspected adverse reactions

Reporting suspected adverse reactions after medicine authorization is important. It allows continued monitoring of the benefit-risk balance of the medicine. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, are encouraged to report any suspected adverse reactions and lack of therapeutic 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 ºC. Keep out of reach and sight of children.

Packaging. 5 suppositories in a blister, 1 or 2 blisters per cardboard box.

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

Manufacturer.

INNOTHERA CHOUZY, France.

Manufacturer's address and location.

Rue René 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.