Lomexin

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT LO MEXIN® (LOMEXIN)

Composition:

Active substance: fenticonazole nitrate;

1 g of cream contains fenticonazole nitrate 20 mg;

Excipients: propylene glycol, hydrogenated lanolin, almond oil, polyglycol ethers of fatty acids, cetostearyl alcohol, glycerol monostearate, edetate sodium, purified water.

Pharmaceutical form. Vaginal cream.

Main physicochemical characteristics: homogeneous white-colored cream.

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 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 activity against gram-positive microorganisms.

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

Lomexin® 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 was absorbed through the vaginal mucosa in women.

In preclinical studies, Lomexin® showed no mutagenic potential and did not induce hypersensitivity, phototoxicity, or photoallergy.

Animal studies did not reveal any effect of fenticonazole nitrate on the function of male or female genital glands or on the 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.

Interaction with other medicinal products and other forms of interaction.

Fatty substances and oils contained in the vaginal cream 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 the vaginal cream (hydrogenated lanolin, cetyl alcohol) may cause local skin reactions (e.g., contact dermatitis); propylene glycol may cause skin irritation. If local hypersensitivity or allergic reactions occur, 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);
• history of sexually transmitted infections, or if the partner is infected with a sexually transmitted infection;
• 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;
• any adverse effects such as erythema, itching, or rash occur, which may be related to treatment.

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

When using the medicinal product, follow the recommendations provided in this instruction.

Before use, ensure the applicator is perfectly clean.

The applicator should be washed with warm soapy water after each use.

The applicator should be sterilized only if recommended by a physician for any reason. However, water exceeding 50 °C or organic solvents should not be used for sterilization. Dry the applicator thoroughly and store it in the container in which the applicator was originally packaged.

Use during pregnancy or breastfeeding

Since there are no data from clinical studies on the use of the drug during pregnancy or breastfeeding, it should not be administered during these periods.

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

Administered intravaginally.

The contents of one applicator—approximately 5 g—are inserted deep into the vagina. The medication should be administered at bedtime using a clean, reusable applicator. If necessary, additional administration may be performed in the morning.

To prevent reinfection, it is recommended to simultaneously treat the patient’s sexual partner locally by applying Lomexin® cream to the glans penis and foreskin.

Instructions for using the cream with the applicator:

1. Screw the applicator onto the tube at the location where the cap is normally screwed on.
2. Gently squeeze the lower part of the tube until the applicator is filled. If resistance occurs, carefully pull back the plunger of the applicator. Fill the applicator completely, unless otherwise directed by a physician.
3. Unscrew the applicator and immediately close the tube with the cap.
4. Lie down in a horizontal position, bend the knees, and spread the legs. Slowly and carefully insert the applicator as deeply as possible into the vagina. Fully depress the plunger. Remove the applicator without touching the plunger.

Children

The medication is not intended for use in children.

Overdose. There have been no reports of overdose. Lomexin® is intended for topical use only, 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, so systemic adverse reactions are not expected. Mild, transient burning sensation may occur after application. Prolonged use of the product may lead to increased sensitivity.

The table below lists adverse reactions reported during clinical studies or in the post-marketing period, classified according to MedDRA organ system classes 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 frequency cannot be estimated from the available data).

_

Shelf life. 3 years.

Suitable for use within 30 days after first opening.

Storage conditions.

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

Packaging.

78 g of cream in an aluminum tube, 1 tube with an applicator, packed in a polystyrene container, in a cardboard box.

Availability. Over-the-counter.

Manufacturer.

Recordati Industria Chimica e Farmaceutica S.p.A.

Manufacturer's address.

Via M. Civitali 1, 20148, Milan, Italy.

Marketing Authorisation Holder.

Recordati Ireland Ltd.

Address of the Marketing Authorisation Holder.

Rehins East, Ringaskiddy, Co. Cork, Ireland.

INSTRUCTIONS FOR MEDICAL USE

of the medicinal product

LOMEXIN ®

(LOMEXIN)

Composition:

Active substance: fenticonazole nitrate;

1 g of cream contains fenticonazole nitrate 20 mg;

Excipients: propylene glycol, hydrogenated lanolin, almond oil, polyglycolized fatty acid esters, cetyl alcohol, glycerol monostearate, sodium edetate, purified water.

Pharmaceutical form. Vaginal cream.

Main physicochemical properties: homogeneous white-colored cream.

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 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 exerts antibacterial activity against gram-positive microorganisms.

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

Lomexin® 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.

In preclinical studies, Lomexin® showed no mutagenic potential and did not induce hypersensitivity, phototoxicity, or photoallergy.

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

Clinical characteristics.

Indications.

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

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

Fatty substances and oils contained in the vaginal cream 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 the vaginal cream (hydrogenated lanolin, cetyl alcohol) may cause local skin reactions (e.g. contact dermatitis). Propylene glycol may cause skin irritation. If local hypersensitivity or 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);
• 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 dysuria;
• any adverse effects occur, such as erythema, itching, or rash, which may be associated with treatment.

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

When using the medicinal product, follow the recommendations provided in this instruction.

Before use, ensure the applicator is perfectly clean.

The applicator should be washed with warm soapy water after each use.

The applicator should be sterilized if recommended by a physician for any reason. However, do not use water above 50 °C or organic solvents for sterilization. Dry the applicator thoroughly and store it in the container in which the applicator was originally packaged.

Use during pregnancy or breastfeeding

As there are no clinical data on the use of the drug during pregnancy or breastfeeding, it should not be used during these periods.

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

Administered intravaginally.

The contents of one applicator—approximately 5 g—are introduced deeply into the vagina. The medication should be used at bedtime with a clean, reusable applicator. If necessary, the medication may additionally be applied in the morning.

To prevent reinfection, it is recommended to simultaneously treat the patient’s sexual partner locally by applying Lomexin® cream to the glans penis and foreskin.

Instructions for using the cream with the applicator:

1. Screw the applicator onto the tube at the cap-threaded end.
2. Gently squeeze the lower part of the tube until the applicator fills. If resistance occurs, carefully pull back the plunger of the applicator. Fill the applicator completely, unless otherwise directed by a physician.
3. Unscrew the applicator and immediately close the tube with the cap.
4. Lie down in a horizontal position, bend the knees, and spread the legs. Slowly and carefully insert the applicator as deeply as possible into the vagina. Fully depress the plunger. Remove the applicator without touching the plunger.

Children

The medication is not intended for use in children.

Overdose
There have been no reports of overdose. Lomexin® is intended for topical use only, 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, so systemic adverse reactions are not expected. A mild, temporary burning sensation may occur after application. Prolonged 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 according to MedDRA organ system and frequency of occurrence: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1000 to < 1/100); rare (≥ 1/10,000 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.

Suitable for use within 30 days after first opening.

Storage conditions.

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

Packaging.

78 g of cream in an aluminum tube, 1 tube per package with an applicator packed in a polystyrene container, in a cardboard box.

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

Manufacturer.

WAMPHARMA S.R.L., Italy

Manufacturer's address and place of business.

VIA KENNEDY, 5, COMAZZO (LO), 26833, Italy.

Marketing Authorization Holder.

Recordati Ailend Ltd.

Address of the Marketing Authorization Holder.

Rehins East, Ringaskiddy, Co. Cork, Ireland.