Epigen intim

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT EPİGEN INTİM

Composition:

Active substance: glycyrrhizic acid;

1 g of spray contains 1 mg of glycyrrhizic acid;

Excipients: maleic acid, fumaric acid, ascorbic acid, folic acid, polysorbate, propylene glycol, purified water.

Pharmaceutical form. Spray.

Main physico-chemical properties: yellow solution with a characteristic odor.

Pharmacotherapeutic group.

Antiviral agents. ATC code D06B B.

Pharmacological Properties

Pharmacodynamics

The active ingredient of Epigen Intim is glycyrrhizic acid, extracted from plant raw material (licorice root).

Glycyrrhizic acid exerts a complex effect, including immunostimulatory, antiviral, anti-inflammatory, and regenerative actions.

The immunostimulatory effect is manifested by an increase in the number and activity of T-lymphocytes, a decrease in immunoglobulin G concentration, and an increase in immunoglobulin A and immunoglobulin M concentrations.

Glycyrrhizic acid induces interferon production, which is one of the components of its antiviral activity.

Glycyrrhizic acid demonstrates antiviral activity against various types of RNA and DNA viruses in vitro and in vivo (Varicella Zoster, herpes simplex virus types I and II, cytomegalovirus, various types of human papillomavirus). Glycyrrhizic acid interrupts viral replication at early stages and induces virion release from the capsid, thereby preventing its penetration into cells.

Glycyrrhizic acid inactivates the aforementioned viruses at concentrations that are non-toxic to normally functioning cells. Mutant viral strains resistant to acyclovir and iodothymidine exhibit the same sensitivity to glycyrrhizic acid as non-mutant strains.

Pharmacokinetics

Following topical and intravaginal administration, glycyrrhizic acid is deposited in the superficial (epidermal) layers of the mucous membrane and skin. Systemic absorption occurs slowly and is detectable in the blood only in trace amounts.

Clinical characteristics.

Indications.

• Treatment of papillomavirus infection.
• Treatment of viral infection caused by herpes simplex virus types I and II.
• Treatment of viral infection caused by Varicella Zoster virus (shingles), as part of combination therapy.
• Prevention of recurrences of viral infections caused by herpes simplex virus types I and II, Varicella Zoster virus, and human papillomavirus.
• Treatment of nonspecific colpitis and vaginitis (as part of combination therapy).

Contraindications.

Hypersensitivity to any component of the drug.

Interaction with other medicinal products and other forms of interaction.

No interactions have been identified with the main groups of medicinal products used in the complex treatment of the above-mentioned diseases (antibiotics and antiseptics, anti-inflammatory and analgesic agents).

Synergism has been observed with concomitant use of activated glycyrrhizic acid and other antiviral drugs, particularly acyclovir derivatives, interferon, and other immunomodulators.

Special precautions for use.

Wash the nozzle with boiled water and soap, and store it in the provided polyethylene packaging. The nozzle design ensures uniform irrigation of the cervix and vaginal walls. In hospital settings, intravaginal irrigation with the drug using speculums can be performed without the nozzle.

Prior cleansing of the application area is not required for effective action.

Discontinue use if signs of intolerance occur.

Use during pregnancy or breastfeeding.

Contraindicated during the first trimester of pregnancy. During the second and third trimesters, the drug should be used only when, in the physician's opinion, the expected benefit to the mother outweighs the potential risk to the fetus/child.

Ability to affect reaction rate while driving or operating machinery.

Does not affect.

Method of Administration and Dosage.

External, intravaginal, and intraurethral administration.

Shake the vial before use.

Hold the vial in an upright position during application.

For external use, in adults and children aged 1 year and older, apply the product to the entire affected skin area by spraying from a distance of 4–5 cm with 1–2 actuations of the valve, which constitutes the optimal therapeutic dose.

For intravaginal use in women, a special spray applicator is provided. Remove the cap from the vial and attach the applicator. Insert the applicator into the vagina and perform 1–2 actuations, which constitutes the optimal therapeutic dose.

For use in men, in addition to external application, the drug should be administered into the external urethral orifice by 1–2 actuations of the spray valve. The duration of treatment is determined by the physician depending on the nature and course of the disease.

Children.

Not recommended for children under 1 year of age.

Overdose.

Not described.

Side effects.

Allergic reactions, skin redness, itching, contact dermatitis.

Shelf life.

3 years.

Storage conditions.

Store at a temperature not exceeding 20 °C in a place inaccessible to children.

Packaging

15 ml or 60 ml in a plastic bottle; 1 bottle with a spray nozzle in a cardboard pack.

Pharmaceutical category.

Over-the-counter (without prescription).

Manufacturer.

B. BRAUN MEDICAL S.A.

Manufacturer's address and location of business activity.

Ronda de Los Olivos, plot 11, Industrial Estate Los Olivos, city of Jaén 23009 (Jaén), Spain.