Gynoxin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT GYNOXIN (GYNOXIN)

Composition:

Active substance: fenticonazole nitrate;

1 capsule contains fenticonazole nitrate 1000 mg;

Excipients: light mineral oil, white soft paraffin, soy lecithin;

Capsule shell: gelatin, glycerin, titanium dioxide (E 171), sodium ethylparahydroxybenzoate, sodium propylparahydroxybenzoate (E 217).

Pharmaceutical form. Vaginal soft capsules.

Main physicochemical properties: soft gelatin capsules of oval shape, ivory color.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives.

ATC code G01AF12.

Pharmacological properties.

Pharmacodynamics.

Gynoxin is a broad-spectrum antifungal agent.

The drug exhibits high fungistatic and fungicidal activity against dermatophytes (all species of Trichophyton, Microsporum, Epidermophyton), Candida albicans, and other fungal infections of the skin and mucous membranes. The drug inhibits acid proteinase of Candida albicans.

The drug also exerts antibacterial action against gram-positive microorganisms.

The mechanism of action of fenticonazole nitrate is believed to involve inhibition of enzyme oxidation by accumulated peroxide and necrosis of fungal cells, manifested by direct action on membranes.

Gynoxin also demonstrates activity against Trichomonas vaginalis in vivo and in vitro.

Pharmacokinetics.

Pharmacokinetic studies have shown minimal absorption through the skin in animals and humans.

A negligible amount of fenticonazole nitrate is absorbed through the vaginal mucosa in women.

During preclinical studies, Gynoxin showed no mutagenic potential and did not promote hypersensitivity, phototoxicity, or photoallergy.

Animal studies revealed no effect of fenticonazole nitrate on the function of male or female reproductive glands or on early stages of reproduction.

Clinical characteristics.

Indications.

• Genital candidiasis (thrush), vulvovaginitis, colpitis, mixed infections of genital mucous membranes;
• vaginal trichomoniasis and mixed vaginal infections caused by Trichomonas vaginalis and Candida albicans.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients of the medicinal product.

Gynoxin, 1000 mg soft vaginal capsules, contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicinal product.

Interaction with other medicinal products and other forms of interaction.

The fatty substances contained in the soft vaginal capsules may damage latex contraceptives.

Patients are advised to use alternative methods of contraception/take preventive measures while using this medicinal product.

Special precautions for use.

Some excipients of soft vaginal capsules (parahydroxybenzoates) may cause allergic reactions (possibly delayed).

If local hypersensitivity or an allergic reaction occurs, treatment should be discontinued.

The patient should consult a physician if:

• symptoms do not improve within one week;
• symptoms recur (more than 2 infections within the past six months);
• history of sexually transmitted infections, or if the partner is infected with a sexually transmitted disease;
• patient's age is under 16 or over 60 years;
• known hypersensitivity to imidazoles or other vaginal antifungal agents;
• presence of any abnormal or irregular vaginal bleeding;
• presence of any vaginal discharge containing blood;
• presence of any vulvovaginal pain, ulcers, or vesicles;
• presence of any lower abdominal pain, which may be associated with the condition being treated, or pain during urination;
• occurrence of any adverse effects such as erythema, itching, or rash, which may be associated with treatment.

Soft vaginal capsules should not be used in combination with barrier contraceptives. If the sexual partner is also infected, appropriate treatment is indicated.

Use during pregnancy or breastfeeding.

The drug should not be used during pregnancy or breastfeeding due to lack of clinical data on its use in these patient groups.

Ability to affect reaction rate while driving or operating machinery.

The drug does not affect the ability to drive or operate machinery.

Method of Administration and Dosage

Administer intravaginally.

Insert 1 capsule deeply into the vagina while lying down, in the evening before bedtime.

Treatment of infections caused by Trichomonas vaginalis and mixed infections (Trichomonas + Candida): apply 1 capsule of 1000 mg. If necessary, repeat administration after 24 hours.

Treatment of infections caused by Candida albicans: apply 1 capsule of 1000 mg once in the evening. If symptoms persist, repeat administration of 1000 mg capsule after 3 days.

Children

The drug is not intended for use in children.

Overdose

Cases of overdose have not been reported. Ginoksin is intended for topical (local) use and not for oral administration. In case of accidental oral intake, abdominal pain and vomiting may occur.

Adverse reactions.

When used as recommended, Gynoxin is practically not absorbed, so systemic adverse reactions are not expected. After application, a mild, temporary burning sensation may occur. Prolonged local use of the drug may lead to increased sensitivity.

The table below lists adverse reactions reported during clinical studies or in the post-marketing period, classified by MedDRA organ system and frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10000 to < 1/1000); very rare (< 1/10000); and frequency not known (when the frequency of the reaction cannot be estimated from available data).

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25 ºC. Keep out of the reach of children.

Packaging.

1 or 2 capsules in a PVC/PVdC/aluminum blister. 1 blister in a cardboard box.

Prescription status. Prescription only.

Manufacturer.

Catalent Italy S.p.A.
Catalent Italy S.p.A.

Manufacturer's address.

Via Nettunense Km. 20, 100 - 04011, Aprilia (LT), Italy
Via Nettunense Km. 20, 100 - 04011, Aprilia (LT), Italy.

Marketing authorization holder.

Recordati Ireland Ltd
Recordati Ireland Ltd.

Address of the marketing authorization holder.

Raheens East, Ringaskiddy, Co. Cork, Ireland
Raheens East, Ringaskiddy, Co. Cork, Ireland.