Colposeptine (Tablets) Instructions for Use

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Laboratoires Macors (France)

ATC Code

G03CC (Estrogens in combination with other drugs)

Active Substances

Chlorquinaldol (Rec.INN registered by WHO)

Promestriene (Rec.INN registered by WHO)

Dosage Form

Colposeptine

Vaginal tablets 10 mg+200 mg: 18 pcs.

Dosage Form, Packaging, and Composition

Vaginal tablets from light yellow to yellow with a brownish or pinkish tint, flat, oblong with rounded ends and with a bevel on both sides; marbling on the surface of the tablets is allowed.

Excipients: lactose monohydrate – 582 mg, microcrystalline cellulose – 300 mg, magnesium stearate – 6 mg, boric acid – 100 mg, sodium lauryl sulfate – 2 mg.

6 pcs. – blisters (3) – cardboard packs^×.

^× protective stickers may be additionally applied.

Clinical-Pharmacological Group

Drug with estrogen-like and antimicrobial action for topical use in gynecology

Pharmacotherapeutic Group

Estrogen + antimicrobial agent – oxyquinoline

Pharmacological Action

A combined agent, the action of which is due to the properties of its constituent components.

Promestriene is a synthetic estrogen-like substance. When applied topically, it promotes the processes of proliferation of the vaginal epithelium, restoration of normal microflora and physiological pH in the vagina.

Chlorquinaldol is an antibacterial agent from the group of 8-hydroxyquinoline derivatives. It has antimicrobial, antiprotozoal, and antifungal action. It is active against gram-negative and gram-positive bacteria (Corynebacterium diphtheria, Streptococcus pyogenes, Staphylococcus aureus, Pseudomonas aeruginosa, Proteus vulgaris, Salmonella, Shigella, Escherichia coli), shows activity against protozoa (Entamoeba histolytica, Lamblia intestinalis, Trichomonas vaginalis), as well as yeast fungi (Candida) and dermatophytes (Trichophyton, Epidermophyton, Microsporum).

Pharmacokinetics

After intravaginal administration, less than 1% of promestriene enters the systemic circulation. Promestriene does not accumulate in organs and tissues. With topical application, there are no systemic hormonal effects, including in estrogen-dependent organs. Promestriene undergoes dealkylation to form two monoesters (3 and 17-beta), is excreted unchanged or partially transformed into estradiol. The T_1/2 of promestriene is less than 24 hours.

The absorption of chlorquinaldol from the vagina is very low. After vaginal administration, Chlorquinaldol was not detected in blood plasma.

Indications

Atrophic vaginitis due to estrogen deficiency, nonspecific bacterial and candidal vaginitis.

ICD codes

Dosage Regimen

Administer one vaginal tablet intravaginally, once daily at bedtime.

Insert the tablet deep into the vagina while lying down.

Continue the treatment for the full course of 18 consecutive days.

Do not interrupt the course during menstruation.

Wash hands thoroughly before and after administration.

Use the applicator if provided for correct placement.

Complete the entire prescribed course even if symptoms improve earlier.

Consult a physician if no improvement is observed after the initial treatment period.

Adverse Reactions

Possible irritation of the vaginal mucosa, burning and itching in the vagina, allergic reactions.

Contraindications

Diagnosed estrogen-dependent malignant neoplasms (of the breast, uterus, ovaries, or vagina) or suspicion of them; simultaneous use with spermicides; genital bleeding of unknown etiology; pregnancy, breastfeeding period; hypersensitivity to the components of the agent; children under 18 years of age.

Use in Pregnancy and Lactation

Adequate and controlled studies in pregnant women have not been conducted.

Given the lack of data on the penetration of active substances through the placental barrier and into breast milk, the risk to the fetus or child cannot be excluded. Use during pregnancy and breastfeeding is contraindicated.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Special Precautions

Before starting treatment, a clinical and gynecological examination should be performed. Medical supervision is necessary throughout the entire treatment period.

In case of vaginal bleeding of unknown etiology, an examination should be performed.

Chlorquinaldol is a halogenated hydroxyquinoline. Cases of cross-allergic reaction with other halogenated hydroxyquinolines – clioquinol – are known.

If clinical signs of infection persist after completion of treatment, a repeat microbiological examination should be performed to confirm the diagnosis.

If adverse reactions occur, the use of the agent should be discontinued and a doctor should be consulted.

During treatment, it is recommended to refrain from sexual intercourse.

Drug Interactions

Concomitant use with spermicides is not recommended, as inactivation of their contraceptive effect is possible.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.