Farmaginax (Suppositories) Instructions for Use

Marketing Authorization Holder

S.C. Rompharm Company S.R.L. (Romania)

ATC Code

G02BB (Intravaginal contraceptives)

Active Substance

Benzalkonium chloride (Rec.INN registered by WHO)

Dosage Form

Farmaginax

Vaginal suppositories 18.9 mg: 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories white or light yellow in color, one end is pointed, the other has a funnel-shaped depression, homogeneous in longitudinal section.

Excipients: semisynthetic glycerides.

5 pcs. – contour cell packs (1) – cardboard boxes.
5 pcs. – contour cell packs (2) – cardboard boxes.

Clinical-Pharmacological Group

Vaginal contraceptive with spermicidal action

Pharmacotherapeutic Group

Contraceptive agent for topical application

Pharmacological Action

Antiseptic with spermicidal action. It is a quaternary ammonium compound, belongs to cationic surfactants.

The spermicidal action is due to the ability of the active substance to destroy sperm membranes (first the flagella, then the heads), which makes it impossible for the egg to be fertilized by a damaged sperm.

The effect develops 5-10 minutes after insertion into the vagina.

Does not affect the normal vaginal microflora or the menstrual cycle.

In vitro, Benzalkonium chloride is active against Neisseria gonorrhoeae, Chlamydia spp., Trichomonas vaginalis, Herpes simplex type 2, Staphylococcus aureus. It has low activity against Gardnerella vaginalis, Candida albicans, Haemophilus ducreyi and Treponema pallidum. It is not active against Mycoplasma spp.

Pharmacokinetics

Benzalkonium chloride is not absorbed into the vaginal mucosa, it is removed by simple washing with water and with normal physiological secretions. When applied topically, it is practically not absorbed.

Indications

Local contraception.

ICD codes

Dosage Regimen

Insert one suppository deeply into the vagina 5-10 minutes before each sexual intercourse.

Ensure the suppository is placed correctly for optimal spermicidal effect.

The contraceptive action develops within the specified time frame after insertion.

For repeated intercourse, insert a new suppository each time.

Do not use for vaginal hygiene or as a lubricant.

Avoid genital hygiene with soap for 2 hours before and 2 hours after application, as soap inactivates the active substance.

Perform vaginal douching no sooner than 2 hours after intercourse.

Discontinue use in case of vaginitis, ulceration, or mucosal irritation until the condition resolves.

This method does not protect against sexually transmitted infections, including HIV.

Consult a physician for persistent vaginal symptoms or to discuss long-term contraceptive options.

Adverse Reactions

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

Contraindications

Hypersensitivity to benzalkonium chloride; vaginitis, ulceration and irritation of the vaginal and cervical mucosa.

Use in Pregnancy and Lactation

Not used during pregnancy. Does not have a negative effect on the course of pregnancy. It is not excreted in breast milk, can be used during breastfeeding.

Special Precautions

The effectiveness of contraception depends on the correct use of the drug containing Benzalkonium chloride.

In case of vaginal diseases, the use of benzalkonium chloride should be temporarily discontinued until the end of treatment with vaginal medications.

This method of contraception does not protect against sexually transmitted infections or those caused by HIV.

The use of soap for genital hygiene is prohibited 2 hours before and 2 hours after sexual intercourse, because soap destroys Benzalkonium chloride. Vaginal douching should be applied 2 hours after sexual intercourse.

Drug Interactions

Any drug used intravaginally can reduce the spermicidal effect of benzalkonium chloride.

Benzalkonium chloride is destroyed by soap.

Iodine solutions (including 0.1% iodonate solution) inactivate Benzalkonium chloride.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.