Lomexin vaginal soft capsules 200 mg blister No. 3

Instructions for Lomexin vaginal soft capsules 200 mg blister No. 3

Composition

active ingredient: fenticonazole nitrate;

1 capsule contains 200 mg or 600 mg of fenticonazole nitrate;

excipients (for soft vaginal capsules 200 mg): medium chain triglycerides, colloidal anhydrous silicon dioxide; capsule shell: gelatin, glycerol, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate (E 217);

excipients (for soft vaginal capsules of 600 mg): light mineral oil, white soft paraffin, soy lecithin; capsule shell: gelatin, glycerin, titanium dioxide (E 171), sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate (E 217).

Dosage form

Soft vaginal capsules.

Main physicochemical properties:

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

Soft vaginal capsules 600 mg: soft gelatin capsules, oval in shape, ivory in color.

Pharmacotherapeutic group

Antimicrobial and antiseptic agents used in gynecology. Imidazole derivatives.

ATX code G01A F12.

Pharmacological properties

Pharmacodynamics

Lomexin® 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 the acid proteinase of Candida albicans.

The drug has an antibacterial effect against gram-positive microorganisms.

It is assumed that the mechanism of action of fenticonazole nitrate is inhibition of enzyme oxidation by accumulated peroxide and necrosis of fungal cells, which is manifested by a direct effect on membranes.

Lomexin® also exhibits activity against Trichomonas vaginalis in vivo and in vitro.

Pharmacokinetics

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

A small amount of fenticonazole nitrate was absorbed through the vaginal mucosa in women.

In preclinical studies, Lomexin® did not show mutagenic potential, did not contribute to increased sensitivity, phototoxicity, and photoallergy.

Animal studies have not shown any effect of fenticonazole nitrate on the functions of male or female gonads and on the early stages of reproduction.

Indication

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

Contraindication

Hypersensitivity to the active substance or to any of the excipients of the drug.

Lomexin®, soft vaginal capsules 600 mg, contains soy lecithin. If you are allergic to peanuts or soy, do not use this medicine.

Interaction with other medicinal products and other types of interactions

Fatty substances contained in soft vaginal capsules can damage latex contraceptives.

Patients are advised to use alternative methods of contraception/precautions when using this medicinal product.

Application features

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

In case of local hypersensitivity or allergic reaction, treatment should be discontinued.

The patient should consult a doctor if:

symptoms have not decreased within one week;

symptoms have recurred (more than 2 infections in the last six months);

have had a sexually transmitted disease in the past, or if your partner has been infected with a sexually transmitted disease;

patient's age under 16 years and over 60 years;

known hypersensitivity to imidazoles or other vaginal antifungal drugs;

any abnormal or irregular vaginal bleeding is present;

any vaginal discharge with blood inclusions is present;

any vulvovaginal pain, ulcers, or blisters are present;

any pain in the lower abdomen that may be associated with the disease being treated, or pain when urinating;

any side effects, such as erythema, itching, or rash, that may be associated with treatment are observed.

Vaginal soft 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, as there are no research data on the use of the drug in these groups of patients.

Ability to influence reaction speed when driving vehicles or other mechanisms

The drug does not affect the reaction speed when driving or working with other mechanisms.

Method of administration and doses

Apply intravaginally.

Vaginal soft capsules 200 mg

Vaginal soft capsules 600 mg

Insert 1 capsule deeply into the vagina in a lying position in the evening before going to bed. If symptoms persist, another capsule can be applied after 3 days.

To avoid re-infection, it is recommended to simultaneously treat the patient's sexual partner with Lomexin® cream by applying the cream to the glans penis and foreskin.

Children

The drug should not be used in children.

Overdose

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

Side effects

When used as recommended, Lomexin® is practically not absorbed, so systemic adverse reactions are not expected. A moderate temporary burning sensation may occur after application. Prolonged topical use of the drug may cause hypersensitivity.

The table below lists the adverse reactions reported during clinical trials or during post-marketing use of the drug, according to the MedDRA system organ class and frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (< 1/10,000) and frequency unknown (in cases where the frequency of the reaction cannot be estimated from the available data).

Expiration date

3 years.

Storage conditions

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

Packaging

Soft vaginal capsules 200 mg: 3 or 6 capsules in a PVC/PVDC/aluminum blister. 1 blister in a cardboard box.

Soft vaginal capsules 600 mg: 1 or 2 capsules in a PVC/PVDC/aluminum blister. 1 blister in a cardboard box.

Vacation category

Without a prescription.

Producer

Catalent Italy SpA

Address

Raheens East, Ringaskiddy, Co. Cork, Ireland.

Applicant

Recordati Ireland Ltd.