HEXITEKS

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT HEXITEX (HEXITEX)

Composition:

Active substance: chlorhexidine;

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

Excipients: polyethylene oxide.

Pharmaceutical form. Suppositories.

Main physicochemical properties: white or white with a yellowish tint suppositories; marbling of the surface is acceptable. Presence of an air channel or a cup-shaped depression is permissible.

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

Pharmacological properties.

Pharmacodynamics.

Chlorhexidine digluconate exerts a rapid and pronounced effect against 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. The drug is ineffective 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.

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 spiral, before and after diathermocoagulation of the cervix, before intrauterine examinations).

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 cannot be used together 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 Hexitex pessaries, since the drug is administered intravaginally. Concomitant use with iodine is not recommended.

Special precautions.

Use during pregnancy or breastfeeding.

Not contraindicated.

Ability to affect reaction speed when driving or operating machinery.

No effect.

Method of Administration and Dosage

The medicinal product is intended for intravaginal use. Before administration, remove the suppository from its blister packaging.

Treatment: administer 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.

Prevention of sexually transmitted diseases: administer a single dose of 1 suppository no later than 2 hours after sexual intercourse.

Pregnancy. The medicinal product should be administered once or twice daily, 1 suppository per dose, as monotherapy or as part of combination therapy, taking into account the severity of the infectious process, bacteriological test results, and presence of signs indicating a threat of pregnancy interruption. Duration of use is 5 to 10 days.

During breastfeeding, the drug should be used at the standard recommended doses.

Children.

There is no experience with use in children.

Overdose.

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

Side effects.

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

Shelf life.

3 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 °C.

Keep out of reach of children.

Packaging.

5 pesarios per strip, 1 or 2 strips per cardboard pack.

Availability category.

Over-the-counter.

Manufacturer.

Ukrainian-Spanish joint venture "Sperco Ukraine".

Manufacturer's address and location of business activity.

21027, Vinnytsia, vul. 600-richchia, 25, Ukraine.

Tel.: +38 (0432) 52-30-36.

E-mail: [email protected] www.sperco.ua