Lomexin

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LOMEXIN®

Composition:

Active substance: fenticonazole nitrate;

1 capsule contains fenticonazole nitrate 200 mg or 600 mg;

Excipients (for 200 mg vaginal soft capsules): medium-chain triglycerides, colloidal anhydrous silicon dioxide; capsule shell: gelatin, glycerin, titanium dioxide (E 171), sodium ethylparahydroxybenzoate, sodium propylparahydroxybenzoate (E 217);

Excipients (for 600 mg vaginal soft capsules): 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:

200 mg vaginal soft capsules: soft gelatin capsules, teardrop-shaped, ivory-colored;

600 mg vaginal soft capsules: soft gelatin capsules, oval-shaped, ivory-colored.

Pharmacotherapeutic group.

Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives.

ATC code G01AF12.

Pharmacological Properties.

Pharmacodynamics.

Lomexin**®** is a broad-spectrum antifungal agent.

The drug demonstrates 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 exerts antibacterial effects 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.

Lomexin**®** also shows activity against Trichomonas vaginalis both 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.

In preclinical studies, Lomexin**®** showed no mutagenic potential and did not increase sensitivity, phototoxicity, or photoallergy.

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

Clinical characteristics.

Indications.

• Genital candidiasis (thrush), vulvovaginitis, colpitis, mixed infections of genital mucous membranes.

Contraindications.

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

Lomexin®, 600 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.

Lipid components contained in soft vaginal capsules may damage latex contraceptives.

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

Special precautions for use

Some of the excipients in 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 last six months);
• there is a history of sexually transmitted infections, or if the partner is infected with a sexually transmitted disease;
• the patient is under 16 or over 60 years of age;
• there is known hypersensitivity to imidazoles or other vaginal antifungal agents;
• any abnormal or irregular vaginal bleeding is present;
• there are any vaginal discharges containing blood;
• there are any vulvovaginal pain, ulcers, or vesicles;
• there is any lower abdominal pain, which may be associated with the condition being treated, or pain during urination;
• any adverse effects such as erythema, itching, or rash occur, which may be related to treatment.

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

Use during pregnancy or lactation.

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 influence reaction rate when driving or operating machinery.

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

Method of Administration and Dosage

Administer intravaginally.

Soft vaginal capsules 200 mg

Insert 1 capsule deeply into the vagina while lying down, in the evening before bedtime. Treatment duration – 3 days, or as recommended by the physician.

Soft vaginal capsules 600 mg

Insert 1 capsule deeply into the vagina while lying down, in the evening before bedtime. If symptoms persist, another capsule may be administered 3 days later.

To prevent reinfection, it is recommended to simultaneously treat the patient's sexual partner locally with Lomexin**®** cream, applied to the glans penis and foreskin.

Children

The drug is not intended for use in children.

Overdose

There have been no reports of overdose. Lomexin® is intended for local use only and not for oral administration. In case of accidental oral ingestion, abdominal pain and vomiting may occur.

Adverse Reactions

When used as recommended, Lomexin® is practically not absorbed; therefore, systemic adverse reactions are not expected. After application, a mild, transient burning sensation may occur. Prolonged local use of the product may lead to increased sensitivity.

The table below lists adverse reactions reported during clinical trials or in the post-marketing period, classified according to MedDRA organ systems and frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 to < 1/1000); very rare (< 1/10,000); and frequency not known (when the frequency cannot be estimated from the available data).

Shelf life. 3 years.

Storage conditions.

Store at a temperature not exceeding 25°C. Keep out of reach of children.

Packaging.

Vaginal soft capsules 200 mg: 3 or 6 capsules in a PVC/PVdC/Aluminum blister. 1 blister per cardboard box.

Vaginal soft capsules 600 mg: 1 or 2 capsules in a PVC/PVdC/Aluminum blister. 1 blister per cardboard box.

Availability. Over-the-counter (without prescription).

Manufacturer.

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

Manufacturer's address.

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

Marketing Authorisation Holder.

Recordati Ireland Ltd.

Address of the Marketing Authorisation Holder.

Raheens East, Ringaskiddy, Co. Cork, Ireland.