Elzhina^® (Tablets) Instructions for Use

Marketing Authorization Holder

Vertex, JSC (Russia)

Contact Information

VERTEX JSC (Russia)

ATC Code

G01BA (Antibacterial agents in combination with corticosteroids)

Dosage Form

Elzhina®

Vaginal tablets: 3, 6, or 9 pcs.

Dosage Form, Packaging, and Composition

Vaginal tablets white or almost white with a yellowish tint, flat, oblong in shape with a bevel; marbling is allowed.

Excipients: lactose monohydrate – 305.4 mg, potato starch – 90 mg, crospovidone – 24 mg, povidone K17 (low molecular weight polyvinylpyrrolidone) – 19 mg, talc – 18 mg, calcium stearate – 12 mg, colloidal silicon dioxide – 12 mg, polysorbate-20 – 3 mg.

3 pcs. – contour cell packs (1) – cardboard packs.
3 pcs. – contour cell packs (2) – cardboard packs.
3 pcs. – contour cell packs (3) – cardboard packs.
3 pcs. – contour cell packs (1) with applicator – plastic trays (1) – cardboard packs.
3 pcs. – contour cell packs (2) with applicator – plastic trays (1) – cardboard packs.
3 pcs. – contour cell packs (3) with applicator – plastic trays (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with antibacterial, antiprotozoal, antifungal, and anti-inflammatory action for topical use in gynecology

Pharmacotherapeutic Group

Antimicrobial agents and antiseptics used in gynecology; antimicrobial agents and antiseptics in combination with corticosteroids

Pharmacological Action

A combined drug with antibacterial, antiprotozoal, antifungal, and anti-inflammatory action for topical use in gynecology, the effectiveness of which is due to the combined action of its components.

Ornidazole is an antiprotozoal agent with antimicrobial action. Active against Trichomonas vaginalis, Entamoeba histolytica, Giardia lamblia (Giardia intestinalis), as well as some anaerobic bacteria such as Bacteroides spp. and Clostridium spp., Fusobacterium spp. and anaerobic cocci: Peptostreptococcus spp. The mechanism of action is due to the inhibition of synthesis and damage to the DNA structure of pathogens.

Neomycin is a broad-spectrum antibiotic from the aminoglycoside group. Active against a number of gram-positive and gram-negative aerobic microorganisms. The development of microbial resistance to neomycin is slow and to a small extent.

Econazole combines antifungal action against dermatophytes Trichophyton spp., Microsporum spp., Epidermophyton spp., yeast and yeast-like fungi of the genus Candida with antibacterial action against gram-positive bacteria Staphylococcus spp., Streptococcus spp. The mechanism of action involves the suppression of ergosterol synthesis in the fungal cell membrane. It acts fungicidally and bactericidally.

Prednisolone is a dehydrogenated analogue of hydrocortisone, it has anti-inflammatory, anti-allergic, and antipruritic effects. It helps to quickly reduce itching and burning.

Pharmacokinetics

With intravaginal use, the systemic absorption of the active substances is insignificant; the drug is practically not absorbed from the surface of the vaginal mucosa.

Indications

• Bacterial vaginitis;
• Vulvovaginitis caused by fungi of the genus Candida;
• Vaginitis caused by mixed infection.

ICD codes

Dosage Regimen

The drug is used intravaginally. 1 vaginal tablet daily at bedtime.

The average duration of the treatment course is 6-9 days.

Before using the drug, it is recommended to wash your hands and perform genital hygiene.

Insertion of vaginal tablets with an applicator

Remove the applicator from the package, prepare the blister with Elzhina^® vaginal tablets and water at room temperature.

Remove one tablet from the package and moisten it in water for 20-30 seconds.

Pull the applicator plunger out all the way (1). Place the moistened vaginal tablet into the special hole of the applicator until it stops (2).

In a supine position, with legs slightly bent, carefully insert the applicator into the vagina as deeply as possible, but without causing discomfort. Slowly press the applicator plunger all the way to insert the tablet into the vagina.

Carefully remove the applicator. After inserting the tablet, you should lie down for 10-15 minutes.

After use, completely remove the plunger from the applicator body, wash the plunger and body with warm soapy water, then with warm running water, and dry.

Do not place the applicator in hot water or boiling water.

Do not use the applicator if it is damaged.

Insertion of vaginal tablets without an applicator

Prepare the blister with Elzhina^® vaginal tablets and water at room temperature.

Remove one tablet from the package and moisten it in water for 20-30 seconds.

In a supine position, with legs slightly bent, carefully insert the tablet into the vagina as deeply as possible using the middle finger.

After inserting the tablet, you should lie down for 10-15 minutes.

Adverse Reactions

Skin and subcutaneous tissue disorders skin peeling, erythema.

Allergic reactions angioedema, urticaria, contact dermatitis.

Local reactions burning, pain, irritation and swelling at the site of application, vaginal dryness (especially at the beginning of treatment). However, these adverse reactions may also be related to the symptoms of vaginal infection.

If any of the side effects listed in the instructions worsen, or any other side effects not listed in the instructions are noted, the patient should discontinue the drug and inform the doctor.

Contraindications

• Hypersensitivity to ornidazole, econazole and other imidazole/nitroimidazole derivatives, neomycin and other aminoglycosides, prednisolone, as well as to any of the components included in the drug;
• Organic diseases of the CNS;
• Diseases of the hematopoietic system (leukemia, hemopoiesis disorders);
• Pregnancy;
• Breastfeeding period;
• Children under 18 years of age.

With caution

• Liver dysfunction;
• Concomitant use of indirect anticoagulants (warfarin, acenocoumarol);
• Alcoholism.

Use in Pregnancy and Lactation

The drug is contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

The drug should be prescribed with caution in cases of liver dysfunction.

Pediatric Use

The use of the drug is contraindicated in children and adolescents under 18 years of age.

Special Precautions

The drug Elzhina^® is intended for intravaginal use only.

The drug contains excipients that sometimes do not completely dissolve in the vagina. Therefore, residues of the vaginal tablet may be found on underwear. This does not affect the effectiveness of the drug.

During treatment, it is recommended to change pads and underwear more often.

If the symptoms of the disease persist after completing the course of treatment, the patient should consult a doctor to clarify the diagnosis.

During treatment, sexual intercourse should be avoided.

It is recommended to consult a doctor about the need for simultaneous treatment of the sexual partner.

The medicinal product should not be passed on to other persons, as it may harm them even if they have the same symptoms as the patient.

Effect on the ability to drive vehicles and mechanisms

The drug Elzhina^® does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Overdose is unlikely with intravaginal use according to the instructions.

In case of accidental ingestion of the drug, the following symptoms may occur: loss of consciousness, headache, dizziness, tremor, convulsions, nausea, vomiting, diarrhea.

Treatment symptomatic therapy.

Drug Interactions

Since the active substances included in the vaginal tablets are absorbed insignificantly, interaction with other drugs during intravaginal use is unlikely. However, patients taking indirect anticoagulants such as warfarin and acenocoumarol should exercise caution and monitor blood coagulation parameters.

Patients are advised to inform the doctor about simultaneous treatment with other drugs.

Storage Conditions

The drug should be stored out of the reach of children, protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

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.