Ledisept-pharmex

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT LEDESEPT-PHARMEKS

Composition:

Active substance: chlorhexidine;

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

Excipient: polyethylene oxide.

Pharmaceutical form. Suppositories.

Main physicochemical properties: suppositories are white to white with a yellowish tint; marbling of the surface is acceptable. The presence of a funnel-shaped depression and an air channel is acceptable.

Pharmacotherapeutic group.

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

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 exert systemic effects.

Clinical characteristics.

Indications.

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 device insertion, before and after cervical diathermocoagulation, 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 bigluconate cannot be used together with detergents containing anionic groups (saponins, sodium lauryl sulfate, sodium carboxymethylcellulose), as well as with soap.

Special precautions for use.

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

Administer the drug intravaginally. Before use, remove the suppository from its blister packaging.

Treatment: use 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: use 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 signs of threatened pregnancy termination, 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 drug may be used at the standard recommended doses.

Children.

There is no experience of use in children.

Overdose.

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

Adverse reactions.

Allergic reactions and itching at the site of suppository insertion are possible.

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 suppositories per strip, 2 strips per pack.

Availability. Over-the-counter (without prescription).

Manufacturer.

LLC "FARMEX GROUP".

Manufacturer's address.

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

All cases of adverse reactions should be reported to the manufacturer:

LLC "FARMEX GROUP", 100 Shevchenka St., Boryspil, Kyiv region, 08301, Ukraine, tel.: +38(044)391-19-19, fax: +38(044)391-19-18, or via the form on the website: http://www.pharmex.com.ua/kontakty/farmakonadzor