Ginocare^® (Spray) Instructions for Use

Marketing Authorization Holder

Sintez PJSC (Russia)

Contact Information

BINNOPHARM GROUP LLC (Russia)

ATC Code

D06BB (Antiviral drugs)

Active Substance

Ammonium glycyrrhizate (Ph.Eur. European Pharmacopoeia)

Dosage Form

Ginocare®

Topical and external use spray 0.1%: 15 ml or 60 ml bottle

Dosage Form, Packaging, and Composition

Spray for topical and external use in the form of a transparent solution from light yellow to yellow or from light brown to brown in color, having a characteristic odor; the presence of sediment is allowed.

Excipients: malic acid, fumaric acid, ascorbic acid, folic acid, propylene glycol, Tween-80 (polysorbate-80), purified water.

15 ml – polyethylene bottles* (1) – cardboard boxes.
60 ml – polyethylene bottles* (1) – cardboard boxes.

* with a spray nozzle for external use with a protective cap; complete with a spray nozzle for intravaginal application in individual packaging.

Clinical-Pharmacological Group

Antiviral drug for external and topical use

Pharmacotherapeutic Group

Antibiotics and antimicrobial agents used in dermatology; antimicrobial agents for topical use; antiviral agents

Pharmacological Action

The active substance of the drug is activated glycyrrhizic acid, obtained by extraction from plant raw materials (licorice root).

Activated glycyrrhizic acid has a complex effect, which includes immunostimulatory, antiviral, anti-inflammatory, antipruritic, and regenerative effects.

Activated glycyrrhizic acid induces the production of the body’s own interferons.

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

Activated glycyrrhizic acid has an antiviral effect on various types of DNA and RNA viruses in vitro and in vivo (Varicella Zoster; herpes simplex virus type I and II; cytomegalovirus, various types of human papillomavirus, including oncogenic ones).

Activated glycyrrhizic acid interrupts virus replication at early stages, causing the virion to exit the capsid, thereby preventing its penetration into cells.

Activated glycyrrhizic acid inactivates these viruses at concentrations that are non-toxic to normally functioning cells.

The anti-inflammatory activity of activated glycyrrhizic acid is combined with a stimulating effect on humoral and cellular immunity factors.

Activated glycyrrhizic acid significantly inhibits the release of kinins and the synthesis of prostaglandins by connective tissue cells in the inflammation zone.

The regenerative effect is due to the improvement of skin and mucous membrane repair.

Pharmacokinetics

Absorption and distribution

With external and topical application, activated glycyrrhizic acid is deposited in the lesions. Systemic absorption occurs slowly. The drug is detected in the blood in trace amounts.

Indications

For adults aged 18 years and older

• Treatment of viral infection caused by human papillomavirus, including asymptomatic excretion of high oncogenic risk human papillomavirus as part of complex therapy;
• Treatment of viral infection caused by herpes simplex virus types I and II as part of complex therapy;
• Treatment of viral infection caused by Varicella Zoster virus (herpes zoster) as part of complex therapy:
• Treatment of viral infection caused by cytomegalovirus as part of complex therapy;
• Prevention of recurrences of viral infections caused by herpes simplex virus types I and II, Varicella Zoster virus, human papillomavirus, cytomegalovirus;
• Prevention and treatment of condylomata acuminata and cervical pathology caused by human papillomavirus, cytomegalovirus;
• Prevention and treatment of conditions accompanied by decreased local immunity, including nonspecific vulvovaginitis, candidal vulvovaginitis and bacterial vaginosis as part of complex therapy;
• For symptoms of discomfort in the genital area, accompanied by itching, burning and dryness of the mucous membranes, including after sexual intercourse;
• For symptoms of discomfort in the genital area, accompanied by itching, burning and dryness of the mucous membranes in ovarian insufficiency.

ICD codes

Dosage Regimen

For herpesvirus infection type I, herpes zoster the drug is recommended to be applied 6 times/day to the lesion for 5 days. In case of persistent infectious process, the treatment period is extended until the symptoms of the disease completely disappear.

For herpesvirus infection type II (genital herpes), cytomegalovirus infection it is recommended to apply 5 times/day for 14 days externally and intravaginally, after relief of relapse – externally and intravaginally 3 times/day for 10 days.

For the prevention of recurrences of genital herpes and cytomegalovirus infection the drug is recommended to be applied externally and intravaginally from the 18th-20th day of the menstrual cycle until the end of menstruation 2 times/day, in the morning and evening.

For papillomavirus infection the drug is recommended to be applied

• Before removal of condylomas – 3 times/day throughout the entire period of etiotropic therapy;
• Against the background of destruction – 5 times/day for 10 days or more until complete healing;
• For prevention of immediate recurrences – 3 times/day for 1 month.

For prevention of progression of papillomavirus infection it is recommended to apply before and after sexual intercourse, as well as when provoking factors occur (stress, overwork, respiratory viral infections, microflora disturbance, antibiotic intake, cytostatics) – 3 times/day intravaginally and externally throughout the entire period of exposure to provoking factors.

For bacterial vaginosis, nonspecific vulvovaginitis and candidal vulvovaginitis the drug is recommended to be applied intravaginally 3-4 times/day for 7-10 days. If necessary, repeat the course of treatment after 10 days. When provoking factors occur (respiratory viral infections, antibiotic intake, cytostatics) – 3 times/day intravaginally and externally throughout the entire period of exposure to provoking factors.

For symptoms of discomfort in the genital area, accompanied by itching, burning and dryness of the mucous membranes – 2 times/day (morning and evening) for 2-3 weeks. For the prevention of discomfort conditions, apply regularly after sexual intercourse.

Special patient groups

Data are not available.

Method of application

Externally, intravaginally and intraurethrally.

Shake the bottle before use.

When using, hold the bottle in a vertical position.

For external use the drug is applied to the entire affected skin surface from a distance of 4-5 cm by a single press of the valve for 2-3 seconds.

For intravaginal application of the drug, a special nozzle with a spray is attached. Remove the valve from the spray bottle and put the nozzle valve on. Then insert the nozzle into the vagina and perform injection by a single press of the nozzle for 2-3 seconds.

For intraurethral application the drug is injected into the external opening of the urethra by a single press of the spray valve for 2-3 seconds.

Adverse Reactions

The frequency of adverse reactions is defined as follows: very common (≥1/10), common (≥1/100 but <1/10), uncommon (≥1/1000 but <1/100), rare (≥1/10000 but <1/1000), very rare (<1/10000), frequency not known (cannot be estimated from the available data).

Skin and subcutaneous tissue disorders: frequency not known – allergic reactions (urticaria, contact dermatitis).

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after drug registration to ensure continuous monitoring of the benefit-risk balance of the drug. Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting system of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to ammonium glycyrrhizinate or to any of the excipients included in the drug.

Use in Pregnancy and Lactation

Pregnancy

Use of the drug during pregnancy is possible if the benefit to the mother outweighs the potential risk to the fetus.

Breastfeeding period

Use of the drug during breastfeeding is possible if the benefit to the mother outweighs the potential risk to the child.

Pediatric Use

Used in adults.

Special Precautions

The nozzle should be washed with boiled water and soap and stored in the supplied polyethylene packaging.

The design of the nozzle allows maintaining the effect of uniform irrigation of the cervix and vaginal walls.

For use in a hospital setting, intravaginal irrigation with the drug in specula can be performed without the nozzle.

For effective action, preliminary washing of the application site is not required.

If signs of intolerance appear, discontinue use of the drug.

Excipients

The drug Ginocare^® contains propylene glycol, which may irritate the skin.

Effect on ability to drive vehicles and mechanisms

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

Overdose

No cases of overdose have been identified.

Drug Interactions

No interaction with the main groups of drugs used for complex treatment of the indicated diseases has been identified (antibiotics and antiseptics; anti-inflammatory and analgesic agents).

Synergism was detected with simultaneous use of activated glycyrrhizic acid and other antiviral drugs, in particular acyclovir derivatives, iodouridine; interferon and other immunomodulators.

Storage Conditions

The drug should be stored at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

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.