Tergynan (Tablets) Instructions for Use

Marketing Authorization Holder

Laboratoires Bouchara-Recordati (France)

Manufactured By

Sophartex (France)

ATC Code

G01BA (Antibacterial agents in combination with corticosteroids)

Dosage Form

Tergynan

Vaginal tablets 65000 IU+100000 IU+3 mg+200 mg: 6 or 10 pcs.

Dosage Form, Packaging, and Composition

Vaginal tablets light yellow in color, with possible inclusions of darker or lighter shades, flat, oblong in shape, with beveled edges and an engraving in the form of the letter “T” on both sides.

Excipients: wheat starch – 264 mg, lactose monohydrate – q.s. to 1.2 g, colloidal silicon dioxide – 6 mg, magnesium stearate – 10 mg, sodium carboxymethyl starch (type A) – 48 mg.

6 pcs. – strips (1) – carton packs.
10 pcs. – strips (1) – carton 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 for topical use in gynecology. It has antimicrobial, anti-inflammatory, antiprotozoal, and antifungal action; ensures the integrity of the vaginal mucosa and the constancy of pH.

Ternidazole is an antifungal agent from the group of imidazole derivatives, it reduces the synthesis of ergosterol (a component of the cell membrane), changes the structure and properties of the cell membrane. It has trichomonacidal action, is also active against anaerobic bacteria, in particular Gardnerella spp.

Neomycin is a broad-spectrum antibiotic from the aminoglycoside group. It acts bactericidally against gram-positive (Staphylococcus, Streptococcus pneumoniae) and gram-negative (Escherichia coli, Shigella dysenteriae, Shigella flexneri, Shigella boydii, Shigella sonnei, Proteus spp.) microorganisms; it is poorly active against Streptococcus spp. The development of microbial resistance is slow and to a small extent.

Nystatin is an antifungal antibiotic from the polyene group, highly effective against yeast-like fungi of the Candida genus, it changes the permeability of cell membranes and slows their growth.

Prednisolone is a dehydrogenated analogue of hydrocortisone, it has a pronounced anti-inflammatory, antiallergic, and anti-exudative effect.

Indications

Treatment of vaginitis caused by susceptible microorganisms, including: bacterial vaginitis; vaginal trichomoniasis; vaginitis caused by Candida fungi; mixed vaginitis.

Prevention of urogenital infections/vaginities, including: before gynecological operations; before childbirth or abortion; before and after IUD insertion; before and after diathermocoagulation of the cervix; before hysterosalpingography.

ICD codes

Dosage Regimen

Administer one vaginal tablet intravaginally, once daily, preferably at bedtime.

For therapeutic treatment of vaginitis, the standard course is 10 consecutive days.

In cases of confirmed fungal infection (mycosis), extend the treatment duration to 20 consecutive days.

For prophylactic use prior to gynecological procedures, administer one tablet daily for 6 consecutive days before the scheduled intervention.

Complete the entire prescribed course of treatment, even if symptoms improve earlier.

Do not interrupt treatment during menstruation; continue administration as prescribed.

Moisten the tablet with a small amount of water immediately prior to insertion to facilitate dissolution.

Adverse Reactions

Local reactions rarely – burning sensation, itching and irritation in the vagina (especially at the beginning of therapy).

Other in some cases – allergic reactions.

Contraindications

Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Can be used from the second trimester of pregnancy.

Use in the first trimester of pregnancy and during lactation (breastfeeding) is possible only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus or infant.

Special Precautions

In case of treatment of vaginitis, trichomoniasis, simultaneous treatment of sexual partners is recommended.

Treatment should not be interrupted during menstruation.

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.