Septofemin (Tablets) Instructions for Use

Marketing Authorization Holder

Alkoy-Pharm, LLC (Russia)

Manufactured By

Aliym, JSC (Russia)

Contact Information

ALKOY-PHARM LLC (Russia)

ATC Code

G01AC05 (Dequalinium)

Active Substance

Dequalinium chloride (Rec.INN registered by WHO)

Dosage Form

Septofemin

Vaginal tablets 10 mg: 6 or 10 pcs.

Dosage Form, Packaging, and Composition

Vaginal tablets white or almost white, biconvex, oval in shape without a score mark.

Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.

6 pcs. – blister packs (1) – cardboard boxes.
10 pcs. – blister packs (1) – cardboard boxes.

Clinical-Pharmacological Group

Topical antiseptic for use in gynecology

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

The drug contains the active substance Dequalinium chloride, which is a quaternary ammonium compound with a broad spectrum of antimicrobial activity. Dequalinium chloride is active against most gram-positive bacteria Streptococcus spp., including (beta-hemolytic streptococci groups A and B), Staphylococcus aureus, Listeria spp.; anaerobes Peptostreptococcus (group D), fungi of the genus Candida ( Candida tropicalis, Candida albicans, Candida glabrata), gram-negative bacteria Gardnerella vaginalis, Escherichia coli, Serratia spp., Klebsiella spp., Pseudomonas spp., Proteus spp., and protozoa ( Trichomonas vaginalis).

Pharmacokinetics

When administered intravaginally, an extremely small amount of dequalinium chloride is absorbed through the vaginal mucosa into the systemic circulation, metabolized to a derivative of 2,2-dicarboxylic acid, and excreted in unconjugated form through the intestine.

Indications

• Bacterial vaginosis;
• Candidal vaginitis;
• Trichomonal vaginitis;
• Sanitation of the vagina before gynecological surgeries and childbirth.

ICD codes

Dosage Regimen

For intravaginal use only. A doctor should be consulted before using the drug.

The recommended dosage regimen is 1 vaginal tablet/day. The vaginal tablet is inserted deep into the vagina in the evening before going to bed, while lying on your back with your legs slightly bent.

The treatment course is 6 days.

If no improvement occurs after treatment, or if symptoms worsen, or if new symptoms appear, it is necessary to consult a doctor. The drug should be used only according to the indications, method of administration, and doses specified in the instructions for use.

Adverse Reactions

Local reactions very rarely – irritation (erosions), itching, burning or redness of the vaginal mucosa; however, these adverse reactions may also be related to the symptoms of a vaginal infection.

General disorders and administration site conditions: very rarely – fever, allergic reactions.

If the patient experiences side effects listed in the instructions, or if they worsen, or if the patient notices any other side effects not listed in the instructions, they should inform their doctor.

Contraindications

• Hypersensitivity to dequalinium chloride and other components of the drug;
• Ulcerative lesions of the vaginal epithelium and cervix;
• Use of the drug Septofemin is not recommended before the onset of sexual activity.

Use in Pregnancy and Lactation

The drug is approved for use during pregnancy and breastfeeding.

Special Precautions

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

In rare cases, with excessive vaginal dryness, there is a possibility that the tablet may remain undissolved. To prevent this, before inserting the vaginal tablet, it should be moistened with water (for 1 second under running water).

During treatment, it is recommended to change pads and underwear more frequently. If clinical signs of infection persist after completion of treatment, a repeat microbiological examination should be performed to identify the pathogen and confirm the diagnosis.

It is recommended to abstain from sexual intercourse during treatment with the drug. To prevent urogenital reinfection, simultaneous treatment of sexual partners is necessary.

When treating vaginal infections, the drug should not be used during menstruation; it is advisable to start treatment after menstruation.

Effect on the ability to drive vehicles and operate machinery

The drug does not affect the performance of potentially hazardous activities requiring increased attention and speed of psychomotor reactions (driving a car, etc.).

Overdose

Symptoms overdose is unlikely when the drug is used in accordance with the instructions for use. In case of accidental ingestion of the drug, side effects may be intensified.

Treatment gastric lavage, symptomatic therapy.

Drug Interactions

Septofemin is incompatible with soap and other anionic surfactants.

Storage Conditions

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

Shelf Life

Shelf life – 3 years. Do not use after the expiration date.

Dispensing Status

The drug is available without a 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.