Hexigin-m®

INSTRUCTIONS for medical use of the medicinal product Hexigin-M®

Composition:

Active substance: chlorhexidine gluconate;

1 suppository contains chlorhexidine gluconate (20%) 85.2 mg, equivalent to 16 mg of 100% chlorhexidine;

Excipients: macrogol 1500, macrogol 400.

Pharmaceutical form. Suppositories.

Main physicochemical properties: white or off-white suppositories; marbled surface is acceptable. Presence of an air channel or funnel-shaped depression in the cross-section is permissible.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents used in gynecology. ATC code G01AX.

Pharmacological properties.

Pharmacodynamics. Chlorhexidine gluconate exerts a rapid and pronounced effect on gram-positive and gram-negative bacteria: Treponema pallidum, Chlamidia spp., Ureaplasma spp., Neisseria gonorrhoeae, Trichomonas vaginalis. Some strains of Pseudomonas spp., Proteus spp. are weakly sensitive to the drug. The drug is not active against 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 prevention of sexually transmitted diseases (syphilis, gonorrhea, trichomoniasis, chlamydia, ureaplasmosis) and infectious-inflammatory complications in obstetrics and gynecology (before surgical treatment of gynecological diseases, before childbirth and abortion, before and after intrauterine contraceptive device insertion, before and after cervical diathermocoagulation, before intrauterine examinations).

For treatment of bacterial vaginosis, colpitis, cervical erosion.

Contraindications.

Individual hypersensitivity to the components of the drug.

Interaction with other medicinal products and other forms of interaction.

Chlorhexidine must not be used concomitantly with detergents containing anionic groups (saponins, sodium lauryl sulfate, sodium carboxymethylcellulose), as well as with soap. The presence of soap may inactivate chlorhexidine; therefore, soap residues must be thoroughly rinsed off before application of the drug. Washing of external genital organs does not affect

the efficacy and tolerability of suppositories, as the drug is administered intravaginally. Concomitant use with iodine is not recommended.

Special precautions for use.

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

Use during pregnancy or breastfeeding. Not contraindicated.

Ability to affect reaction speed when driving or operating machinery. No effect.

Dosage and Administration.

The medicinal product is administered intravaginally. Before administration, the pessary should be removed from the blister pack.

Treatment: 1 pessary once or 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.

Prevention of sexually transmitted diseases: 1 pessary administered as a single dose no later than 2 hours after sexual intercourse.

Pregnancy. Depending on the severity of the infectious process, bacteriological test results, and signs of threatened pregnancy, the drug may be administered as 1 pessary once or twice daily, either as monotherapy or as part of combination therapy. Duration of treatment ranges from 5 to 10 days.

Breastfeeding. The drug may be used during lactation in the standard recommended doses.

Children.

The drug is not administered to children.

Overdose.

No cases of overdose or toxic effects have been reported with the use of this drug.

Side effects.

Allergic reactions and itching at the site of pesarium administration are possible.

A burning sensation and irritation at the site of pesarium administration are possible.

Shelf life.

2 years. Do not use after the expiry date stated on the packaging.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC.

Keep out of reach of children.

Packaging.

5 pesaria per strip made of polyvinyl chloride film. 2 strips per cardboard box.

Pharmaceutical category.

Over-the-counter.

Manufacturer. JSC "Monfarm".

Manufacturer's address and location of business activity.

8, Zavodska Street, Avramivka, Uman district, Cherkasy region, 19161, Ukraine.