Elzhina vaginal pills, No. 9

• bacterial vaginitis caused by banal pyogenic flora;

• vulvovaginitis caused by fungi of the genus Candida;

• vaginitis caused by mixed infection.

Intravaginally.
The vaginal tablet should be inserted deep into the vagina in the supine position, after hygienic treatment of the external genitalia. Before insertion into the vagina, the tablet must be held in cold boiled water for 20-30 seconds. After the introduction of the tablet, you should lie for 10-15 minutes.
Apply intravaginally, one vaginal tablet daily at bedtime.
The average duration of the course of treatment is 6-9 days.
During menstruation, the drug Elzhina is used in the usual way.
If after treatment there is no improvement or new symptoms appear, you should consult your doctor.

One tablet contains:
active substances: ornidazole - 500 mg; neomycin in the form of neomycin sulfate - 65,000 IU; prednisolone in the form of prednisolone sodium phosphate - 3 mg; econazole in the form of econazole nitrate - 100 mg;
excipients: lactose monohydrate - 305.4 mg; potato starch - 90.0 mg; colloidal silicon dioxide - 12.0 mg; povidone (low molecular weight polyvinylpyrrolidone) - 19.0 mg; crospovidone - 24.0 mg; polysorbate-20 - 3.0 mg; calcium stearate - 12.0 mg; talc - 18.0 mg.

• hypersensitivity to ornidazole, econazole and other imidazole / nitroimidazole derivatives, neomycin and other aminoglycosides, prednisolone, as well as to any of the components that make up the drug;

• organic diseases of the central nervous system;

• hematopoietic disorders;

• pregnancy;

• breastfeeding period;

• children under 18 years of age.

Carefully

• liver dysfunction;

• alcoholism.

Trade name: ElzhinaЃ

Group name: Ornidazole + Neomycin + Prednisolone + Econazole

Dosage form: vaginal tablets

Composition
One tablet contains:
active substances: ornidazole - 500 mg; neomycin in the form of neomycin sulfate - 65,000 IU; prednisolone in the form of prednisolone sodium phosphate - 3 mg; econazole in the form of econazole nitrate - 100 mg;
excipients: lactose monohydrate - 305.4 mg; potato starch - 90.0 mg; colloidal silicon dioxide - 12.0 mg; povidone (low molecular weight polyvinylpyrrolidone) - 19.0 mg; crospovidone - 24.0 mg; polysorbate-20 - 3.0 mg; calcium stearate - 12.0 mg; talc - 18.0 mg.

Description
Flat tablets, oblong, beveled, white or white with a yellowish sheen. Marbling is allowed.

Pharmacotherapeutic group
Combined antimicrobial agent (antimicrobial and antiprotozoal agent + aminoglycoside antibiotic + glucocorticosteroid + antifungal agent).

Pharmacological properties
Pharmacodynamics
ElzhinaЃ is a combined preparation with antibacterial, antifungal and anti-inflammatory action for local use in gynecology.
Ornidazole is an antiprotozoal agent with antimicrobial action. Ornidazole is effective 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 inhibition of synthesis and damage to the structure of the DNA of pathogens.
Neomycin is a broad-spectrum antibiotic of the aminoglycoside group. It is active against a number of gram-positive and gram-negative aerobic microorganisms. Resistance of microorganisms to neomycin develops slowly and to a small extent. Practically not absorbed through the mucous membranes.
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 is to suppress the synthesis of ergosterol of the cell membrane of fungi. Acts fungicidal and bactericidal.
Prednisolone - a dehydrated analogue of hydrocortisone, has anti-inflammatory, anti-allergic, and antipruritic effects. Promotes a rapid reduction in itching and burning.

Pharmacokinetics
With intravaginal use, the systemic absorption of active components is negligible, the drug is practically not absorbed from the surface of the vaginal mucosa.

Indications for use

• bacterial vaginitis caused by banal pyogenic flora;

• vulvovaginitis caused by fungi of the genus Candida;

• vaginitis caused by mixed infection.

Contraindications

• hypersensitivity to ornidazole, econazole and other imidazole / nitroimidazole derivatives, neomycin and other aminoglycosides, prednisolone, as well as to any of the components that make up the drug;

• organic diseases of the central nervous system;

• hematopoietic disorders;

• pregnancy;

• breastfeeding period;

• children under 18 years of age.

Carefully

• liver dysfunction;

• alcoholism.

Application during pregnancy and during breastfeeding
Pregnancy
ElzhinaЃ is contraindicated during pregnancy.
Breastfeeding Period
ElzhinaЃ is contraindicated during breastfeeding. If it is necessary to use the drug, breastfeeding should be discontinued.

Method of administration and dosage

Intravaginally.
The vaginal tablet should be inserted deep into the vagina in the supine position, after hygienic treatment of the external genitalia. Before insertion into the vagina, the tablet must be held in cold boiled water for 20-30 seconds. After the introduction of the tablet, you should lie for 10-15 minutes.
Apply intravaginally, one vaginal tablet daily at bedtime.
The average duration of the course of treatment is 6-9 days.
During menstruation, the drug Elzhina is used in the usual way.
If after treatment there is no improvement or new symptoms appear, you should consult your doctor.

Side effect

Skin and subcutaneous tissue
disorders : angioedema, urticaria, contact dermatitis, skin peeling, erythema.
General disorders and reactions at the injection site:
burning, pain, irritation and swelling at the injection site, vaginal dryness (especially at the beginning of treatment).
If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose
With intravaginal use, overdose is unlikely.
If you accidentally take the drug inside, the following symptoms are possible: loss of consciousness, headache, dizziness, tremors, convulsions, nausea, vomiting, diarrhea.
Treatment: symptomatic therapy.

Interaction with other medicinal products

The drug interaction of the drug Elzhina with intravaginal use has not been studied. Despite the fact that the active components that make up the vaginal tablets are slightly absorbed, patients taking indirect anticoagulants such as warfarin and acenocoumarol should be careful and monitor blood coagulation parameters. It is recommended to inform the doctor about the simultaneous treatment with other drugs.

Special instructions
Elzhina vaginal tablets are intended only for intravaginal use, do not use inside.
Despite the fact that clinical studies did not reveal changes in the blood system during treatment with Elzhina, it cannot be used in patients with diseases of the hematopoietic system (leukemia, hematopoietic disorders) at the present time or in history.
When treating with Elzhina, caution should be exercised in patients with diseases of the central nervous system.
To reduce the risk of recurrence of the disease, simultaneous treatment of the sexual partner is recommended.
It is recommended to select reliable contraceptive methods during treatment.
During treatment, you should refrain from sexual intercourse.
In case of severe irritation, treatment should be discontinued.
Read the instructions carefully before you start using the drug. Save the instructions, you may need them again. If you have any questions, see your doctor. The drug you are treating is intended for you personally and should not be passed on to others, as it can harm them even if they have the same symptoms as you.

Influence on the ability to drive vehicles and mechanisms
Elzhina's drug does not affect the ability to drive vehicles or engage in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form
Vaginal tablets 500 mg + 65000 IU + 3 mg + 100 mg.
3 tablets in a blister strip of light-protective polyvinyl chloride film and aluminum foil.
1, 2 or 3 blister packs together with instructions for use in a cardboard box.

Storage
conditions Store in a dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

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

Terms of dispensing
Prescription.