Gynofort^® (Cream) Instructions for Use

Marketing Authorization Holder

Gedeon Richter, Plc. (Hungary)

Contact Information

GEDEON RICHTER JSC (Hungary)

ATC Code

G01AF15 (Butoconazole)

Active Substance

Butoconazole (Rec.INN registered by WHO)

Dosage Form

Gynofort®

Vaginal cream 2%: applicator 5 g

Dosage Form, Packaging, and Composition

Vaginal cream is homogeneous, from white to white with a grayish tint, free from foreign particles and without visible separation.

Excipients: sorbitol, liquid paraffin, glyceryl monostearate, polyglyceryl-3-oleate, wax, colloidal silicon dioxide, disodium edetate, methylparaben, propylparaben, propylene glycol, water.

5 g – polypropylene applicators (1) – polystyrene cases (1) – laminated bags (1) – cardboard packs.

Clinical-Pharmacological Group

A drug with antifungal action for topical use in gynecology

Pharmacotherapeutic Group

Antimicrobial preparations and antiseptics used in gynecology. Antimicrobial preparations and antiseptics, excluding combinations with corticosteroids. Imidazole derivatives

Pharmacological Action

Butoconazole, an imidazole derivative. It has fungicidal activity in vivo against fungi of the genera Candida, Trichophyton, Microsporum, Epidermophyton. The drug is active in vitro against some gram-positive bacteria. Clinical efficacy has been proven for vaginal infections caused by Candida albicans strains.

Imidazoles primarily affect the fungal cell membrane by inhibiting the conversion of lanosterol to ergosterol, which leads to a change in the lipid composition of the membrane. The permeability of the cell changes, leading to a decrease in osmotic resistance and fungal viability.

The vaginal cream is a water-in-oil type emulsion, therefore it has bioadhesive properties. In vivo studies have shown that after intravaginal administration, the bioadhesive cream remains on the vaginal mucosa for an average of 4.2 days.

Pharmacokinetics

Absorption

With intravaginal use, an average of 1.7% of the administered dose is absorbed. C_max of the active substance and its metabolites in blood plasma after intravaginal administration is reached after 13 hours.

Metabolism and Excretion

Butoconazole undergoes intensive metabolism and is excreted by the kidneys and through the intestines.

Indications

• Local therapy of vulvovaginal fungal infections caused by Candida albicans and other species of the genus Candida.

ICD codes

Dosage Regimen

Intravaginally.

The drug Gynofort^® is supplied in a single-use pre-filled syringe-applicator containing 5 g of cream, which corresponds to approximately 100 mg of butoconazole nitrate.

The recommended dose is the contents of one applicator (about 5 g), administered once, deep into the vagina at any time of the day (preferably in the evening).

It is not recommended to use the drug Gynofort^® in children under 14 years of age. Efficacy and safety of the drug in this age group have not been established. Due to limited data regarding the treatment of sexually active adolescents (aged 14 to 18 years) with Gynofort^®, the physician should assess the benefit-risk ratio before prescribing this drug.

Instructions for using the applicator

1. Remove the foil from the package and take out the applicator with the cap. Do not remove the cap. If the cap has been removed, do not use the applicator. Do not heat the applicator before use. Holding the applicator firmly with one hand and pulling the ring with the other, pull the plunger out of the applicator to the limit.
2. Gently insert the applicator as deep as possible into the vagina.
3. Slowly press the plunger to squeeze the cream out of the applicator.
4. Remove the empty applicator from the vagina and discard it.

Adverse Reactions

After using the drug, symptoms such as burning in the area of the external genitalia/vagina, itching, inflammation and swelling, pain or cramps in the lower abdomen or pelvic area, or a combination of two or more of the listed symptoms may occur.

In controlled clinical studies with a single use of Gynofort^®, adverse events were reported by 5.7% of 314 patients, and only in 1% of patients the complaints were related to treatment with this drug.

Gastrointestinal disorders pain in the lower abdomen, cramping in the lower abdomen.

Reproductive system and breast disorders pelvic pain, vaginal inflammation, vaginal swelling, itching in the area of the external genitalia and vagina, burning in the area of the genitalia and vagina.

Allergic reactions may develop.

Contraindications

• Hypersensitivity to butoconazole and/or other components of the drug;
• First trimester of pregnancy;
• Period of breastfeeding (data are not available);
• Women of childbearing age in the absence of reliable contraception;
• Children under 14 years of age (efficacy and safety have not been established).

Use in Pregnancy and Lactation

Pregnancy

Currently, data on the use of butoconazole nitrate during pregnancy are insufficient.

It is not recommended to use the drug Gynofort^® for women in the first trimester of pregnancy or for women of childbearing age in the absence of reliable contraception.

The drug Gynofort^® can be used in the second and third trimesters of pregnancy only if the expected benefit to the woman outweighs the potential risk to the fetus. When using the drug during pregnancy, special care should be taken when inserting the applicator to prevent the possibility of mechanical injury.

Breastfeeding period

It is unknown whether Butoconazole passes into breast milk after intravaginal administration, therefore it is not recommended to use the drug Gynofort^® during breastfeeding.

Pediatric Use

Contraindicated for use in children under 14 years of age (efficacy and safety have not been established).

Due to limited data regarding the treatment of sexually active adolescents (aged 14 to 18 years) with Gynofort^®, the physician should assess the benefit-risk ratio before prescribing this drug.

Special Precautions

Before using the drug, a microscopic and/or culture examination of a vaginal smear should be performed to confirm the diagnosis.

If clinical signs of infection persist after completion of treatment, a repeat microbiological examination should be performed to rule out other pathogens and confirm the diagnosis.

Recurrent vaginal candidiasis that is not amenable to eradication therapy may be an early sign of HIV infection in women at risk of HIV infection.

Due to the prolonged action of the vaginal cream, after using the drug Gynofort^®, it is not recommended to perform vaginal douching or wash the cream out of the vagina for 3 days. For the same reason, sexual intercourse should be avoided for 3 days after applying the cream.

If an allergic reaction or irritation of the vaginal mucosa occurs, treatment should be discontinued.

The drug Gynofort^® contains liquid paraffin, which damages products made of latex or rubber (including condoms or intravaginal diaphragms), therefore, within 72 hours after using the drug Gynofort^®, it is not recommended to use the above-mentioned contraceptive means. Other methods of contraception should be used.

The drug Gynofort^® contains propylene glycol, which may cause skin irritation.

The drug Gynofort^® contains methylparaben and propylparaben, which may cause allergic reactions (possibly delayed type).

Effect on ability to drive vehicles and operate machinery

The drug Gynofort^® does not affect the ability to drive a car and work with machinery.

Overdose

In case of accidental ingestion of the drug Gynofort^®, gastric lavage should be performed as soon as possible and symptomatic therapy should be initiated if necessary.

Drug Interactions

Data on interaction with other medicinal products are not available.

The drug Gynofort^® contains liquid paraffin, which damages products made of latex or rubber (including condoms or intravaginal diaphragms), therefore, within 72 hours after using the drug Gynofort^®, it is not recommended to use the above-mentioned contraceptive means. Other methods of contraception should be used.

Storage Conditions

The drug should be stored out of the reach of children at a temperature from 15°C (59°F) to 25°C (77°F).

Shelf Life

The shelf life is 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

The drug is dispensed by 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.