CHLORHEXIDINE-PHARMEX

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT CHLORHEXIDINE-PHARMEKS (Chlorhexidine-Pharmex)

Composition:

Active substance: chlorhexidine;

1 suppository contains chlorhexidine digluconate, 20% solution, equivalent to 16 mg of chlorhexidine;

Excipient: polyethylene oxide.

Dosage form. Suppositories.

Main physicochemical properties: suppositories are white to white with a yellowish tinge; marbling is permissible. Presence of a funnel-shaped depression and an air core is allowed.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents used in gynecology. ATC code G01A X.

Pharmacological properties.

Pharmacodynamics.

Chlorhexidine bigluconate exerts a rapid and pronounced effect on Gram-positive and Gram-negative bacteria, yeasts, and dermatophytes: Treponema pallidum, Chlamydia spp., Ureaplasma spp., Neisseria gonorrhoeae, Trichomonas vaginalis. Some strains of Pseudomonas spp., Proteus spp. are weakly sensitive to the drug. Resistant to the drug are acid-resistant bacterial forms, bacterial spores, fungi, and viruses.

Pharmacokinetics.

When administered intravaginally, it is practically not absorbed and does not produce systemic effects.

Clinical characteristics.

Indications.

For the prevention of sexually transmitted diseases (syphilis, gonorrhea, trichomoniasis, chlamydia, ureaplasmosis) and infectious-inflammatory complications in obstetrics and gynecology (prior to surgical treatment of gynecological diseases, before childbirth and abortion, before and after insertion of intrauterine contraceptive devices, before and after diathermocoagulation of the cervix, before intrauterine examinations).

For the treatment of bacterial vaginosis, colpitis, cervical erosion.

Contraindications.

Individual hypersensitivity to the components of the drug.

Interaction with other medicinal products and other types of interactions.

Chlorhexidine bigluconate should not be used together with detergents containing anionic groups (saponins, sodium lauryl sulfate, sodium carboxymethylcellulose).

Soap may inactivate chlorhexidine; therefore, soap residues must be thoroughly rinsed off before applying the drug. Washing of external genital organs does not affect the efficacy and tolerability of the pessaries.

Simultaneous use with iodine is not recommended.

Special precautions for use.

Contact of hypochlorite bleaching agents with fabrics previously exposed to chlorhexidine-containing products may cause the appearance of brown stains on the fabric.

Use during pregnancy or breastfeeding.

Not contraindicated.

Ability to influence reaction rate while driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

The medicinal product should be administered intravaginally. Before use, remove the suppository from its contour packaging.

Treatment: apply 1 suppository twice daily for 7–10 days, depending on the nature of the disease. If necessary, the treatment course may be extended up to 20 days.

Prophylaxis of venereal diseases: apply a single dose of 1 suppository no later than 2 hours after sexual intercourse.

Pregnancy. Depending on the severity of the infectious process, results of bacteriological examinations, and presence of risk of pregnancy termination, chlorhexidine digluconate should be used as monotherapy or as part of combination therapy at a dose of 1 suppository 1 or 2 times daily. Duration of use ranges from 5 to 10 days.

During breastfeeding, the medicinal product should be used at the usual recommended doses.

Children.

There is no experience of use.

Overdose.

Overdose and toxic effects have not been observed with the use of this medicinal product.

Side effects.

Allergic reactions, itching at the site of pesario administration, burning, irritation are possible.

Reporting of suspected adverse reactions.

Reporting of adverse reactions after drug registration is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C. Keep out of reach of children.

Packaging. 5 pesarios per strip, 2 strips per cardboard box.

Availability category. Over-the-counter.

Manufacturer.

LLC "FARMEKS GROUP".

Manufacturer's address and location of its business activity.

100, Shevchenka Street, Boryspil, Kyiv region, 08301, Ukraine.