Cervicon^®-DIM (Suppositories) Instructions for Use

Marketing Authorization Holder

Alcea LLC (Russia)

Manufactured By

Altpharm LLC (Russia)

ATC Code

L01XX (Other anticancer drugs)

Active Substance

Diindolylmethane (Grouping name)

Dosage Form

Cervicon®-DIM

Vaginal suppositories 100 mg: 25 pcs.

Dosage Form, Packaging, and Composition

Vaginal suppositories from light pink to yellowish-pink color, torpedo-shaped, with a possible specific odor.

Excipients: hard fat – 1.9795 g, crospovidone – 0.02 g, red carmine dye (E120) – 0.0005 g.

5 pcs. – contour cell packs (5) – cardboard packs.

Clinical-Pharmacological Group

Antineoplastic drug

Pharmacotherapeutic Group

Other antineoplastic preparations

Pharmacological Action

It stimulates the apoptosis of human papillomavirus (HPV)-infected and transformed cells, and is also a stimulator of the expression of receptors to gamma-interferon.

Thus, the therapeutic effect of diindolylmethane is based on its ability to accelerate the elimination of human papillomavirus-infected and transformed cells and to enhance the nonspecific immune response to the infection.

Furthermore, Diindolylmethane normalizes the metabolism of estradiol in HPV-infected cells, preventing the formation of a carcinogenic estrogen metabolite (16α-hydroxyestrone), which stimulates the expression of HPV oncogenes.

By suppressing the expression of the E7 oncogene of the human papillomavirus, Diindolylmethane blocks the hormone-dependent pathological proliferation of HPV-infected cells.

Pharmacokinetics

With intravaginal application, Diindolylmethane has high local bioavailability and practically does not enter the systemic circulation.

Indications

Treatment of dysplasia (cervical intraepithelial neoplasia) of the cervix uteri (regardless of the results of papillomavirus infection detection by PCR).

ICD codes

Dosage Regimen

Administer intravaginally.

Use one 100 mg suppository twice daily (approximately every 12 hours).

Initiate treatment after the cessation of menstruation.

Thoroughly wash hands before and after the administration procedure.

Insert the suppository deeply into the vagina while lying on your back with knees bent.

The duration of therapy is determined by the attending physician based on the dynamics of clinical and laboratory parameters.

Continue treatment for the entire prescribed period, even if symptoms improve.

Refrain from sexual intercourse for the duration of the treatment course.

Use reliable contraception during the treatment period.

Concurrent use of other intravaginal products, particularly oxidizing antiseptics (e.g., iodine, potassium permanganate, hydrogen peroxide), is not recommended.

Discontinue use and consult a physician immediately if severe local irritation, burning, or signs of an allergic reaction occur.

Adverse Reactions

Immune system disorders: frequent – urticaria, pruritus.

Cardiovascular system disorders: infrequent – AV conduction disturbance, signs of myocardial hypoxia on the electrocardiogram, increased blood pressure.

Digestive system disorders: infrequent – diarrhea.

Skin and subcutaneous tissue disorders: infrequent – petechial skin rash, slowed hair growth on the head and body.

Reproductive system and breast disorders: frequent – discomfort, burning, itching in the vagina; leucorrhea and flaky discharge from the genital tract; infrequent – vaginal dryness during sexual intercourse, delayed menstruation.

Laboratory and instrumental data: frequent – increased ALT and AST activity in blood plasma; thrombocytopenia and increased erythrocyte sedimentation rate; bacteriuria, leukocyturia, proteinuria, ketonuria; infrequent – decreased plasma creatinine concentration, leukocytosis in the cervical smear, vaginal dysbiosis.

Contraindications

Hypersensitivity to the components of the product; pregnancy, breastfeeding period; age under 18 years.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and breastfeeding.

Pediatric Use

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

Special Precautions

It is advisable to start treatment after menstruation.

It is recommended to refrain from sexual intercourse during the treatment period.

It is recommended to use contraception during the treatment period.

Drug Interactions

Diindolylmethane should not be used simultaneously with drugs for intravaginal application belonging to the group of oxidizing antiseptics (potassium permanganate, iodine, hydrogen peroxide).

Storage Conditions

Store at 2°C (36°F) to 8°C (46°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.