Hexicon
Ukraine
Table of Contents
I N S T R U C T I O N for medical use of the medicinal product HEXICON
Composition:
Active substance: chlorhexidine;
1 suppository contains 20% solution of chlorhexidine digluconate equivalent to 16 mg of chlorhexidine digluconate;
Excipients: macrogol 400, macrogol 1500.
Dosage form. Suppositories.
Main physicochemical properties: spherical suppositories, white to off-white in color. Presence of an air channel or funnel-shaped depression is acceptable.
Pharmacotherapeutic group.
Antimicrobial and antiseptic agents used in gynecology.
ATC code G01AX.
Pharmacological properties.
Pharmacodynamics. Active against protozoa, Gram-positive and Gram-negative bacteria: 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 has no activity 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).
Prevention of infectious-inflammatory complications in obstetrics and gynecology (prior to surgical treatment of gynecological diseases, before childbirth and abortion, before and after intrauterine contraceptive device insertion, before and after cervical diathermocoagulation, before intrauterine examinations).
Treatment of bacterial vaginosis, colpitis, cervical erosions.
Contraindications.
Individual hypersensitivity to the components of the drug.
Interaction with other medicinal products and other forms of interaction.
Chlorhexidine should not 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, any soap residues must be thoroughly rinsed off before application of the medicinal product. Washing of external genital organs does not affect the efficacy and tolerability of the pessaries, since the drug is administered intravaginally.
Concomitant use with iodine is not recommended.
Special precautions for use.
Contact of hypochlorite bleaching agents with fabrics previously in contact with a product containing chlorhexidine may cause 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.
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, bacteriological test results, and the presence of a threat of pregnancy interruption, apply chlorhexidine bigluconate as 1 suppository once or twice daily, either as monotherapy or as part of combination therapy. Duration of use is 5 to 10 days.
During breastfeeding, the medicinal product may be used at the usual recommended doses.
Children. Experience of use is lacking.
Overdose.
Overdose and toxic effects have not been observed with the use of this medicinal product.
Side effects.
Allergic reactions, itching, burning, irritation at the site of administration may occur.
Shelf life. 3 years.
Storage conditions. Store in the original packaging to protect from light at a temperature of 2 to 8 °C. Keep out of reach of children.
Packaging. 5 suppositories in a contour cell pack. 2 contour cell packs in a cardboard box.
Dispensing category. Over-the-counter.
Manufacturer.
LLC "FZ "STADA", Ukraine.
Manufacturer's address and place of business.
37, Kyivska Street, Bila Tserkva, Kyiv region, 09100, Ukraine.