Lomexin

Package leaflet: Information for the patient

Lomexin 20 mg/g cream, 20 mg/ml cutaneous spray, solution

fenticonazole nitrate
Please read all of this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What Lomexin is and what it is used for
2. What you need to know before using Lomexin
3. How to use Lomexin
4. Possible side effects
5. How to store Lomexin
6. Contents of the pack and other information

1. What Lomexin is and what it is used for

Lomexin contains the active substance fenticonazole nitrate.
It belongs to a group of medicines called topical "antifungals" and works against infections caused by fungi.
Lomexin is used locally (topical use) to treat the following conditions:

• fungal skin infections caused by fungi known as dermatophytes (dermatomycoses due to Trichophyton, Microsporum, Epidermophyton) affecting various parts of the body: scalp ringworm (tinea capitis), body ringworm (tinea corporis), groin ringworm (tinea cruris), athlete’s foot (tinea pedis), hand ringworm (tinea manuum), facial ringworm (tinea faciei), beard ringworm (tinea barbae), nail ringworm (tinea unguium)
• skin infections caused by fungi of the genus Candida (candidiasis such as intertrigo, angular cheilitis, facial candidiasis, diaper candidiasis, perineal and scrotal candidiasis)
• localized infections of certain parts of the male genitals (balanitis, balanoposthitis)
• localized nail infections (onychia and paronychia)
• fungal infection known as “pityriasis versicolor” (due to Pityrosporum orbiculare and P. ovale)
• ear infections caused by fungi (otomycosis due to Candida or molds), only if there are no lesions affecting the eardrum
• a skin infection called “erythrasma”
• fungal infections (mycoses) associated with bacterial superinfections (due to Gram-positive bacteria)

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Lomexin

Do not use Lomexin

• if you are allergic to fenticlozole nitrate or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist if:

• you are pregnant or breastfeeding; in both cases, Lomexin should be used only under medical supervision (see section “Pregnancy, breastfeeding and fertility”);
• you experience any irritation or sensitivity to the product, as treatment should be discontinued and you should consult your doctor, who will advise appropriate therapy.
• prolonged use, for example 3-4 weeks, of topical medicines (topical use) may cause allergic reactions (sensitization phenomena).

Lomexin is for external use only (cutaneous use); do not apply on mucous membranes or on damaged/irritated skin. Avoid contact with the eyes; if contact occurs, rinse thoroughly with water. Lomexin contains excipients with known effects that require specific warnings and precautions (see section “Important information on some excipients”).

Other medicines and Lomexin
Inform your doctor or pharmacist if you are currently using, have recently used, or might use any other medicines.
No studies have been conducted on interactions between Lomexin and other medicines.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
Lomexin should be used during pregnancy and breastfeeding only under medical supervision.

Driving and using machines
Lomexin does not affect or affects negligibly the ability to drive or operate machinery.

Important information on some excipients
Lomexin 20 mg/g cream contains: propylene glycol, cetyl alcohol, hydrogenated lanolin:

• propylene glycol: 50 mg in 1 g of cream. May cause skin irritation. Do not use this medicine in children under 4 weeks of age with open wounds or extensive areas of damaged skin (such as burns) without first consulting your doctor or pharmacist.
• cetyl alcohol and hydrogenated lanolin: may cause local skin reactions (e.g. contact dermatitis).

Lomexin 20 mg/ml cutaneous spray, solution contains: propylene glycol and ethanol.

• propylene glycol: 350 mg in 1 ml of solution. May cause skin irritation. Do not use this medicine in children under 4 weeks of age with open wounds or extensive areas of damaged skin (such as burns) without first consulting your doctor or pharmacist;
• ethanol: 337 mg in 1 ml of solution. May cause a burning sensation on damaged skin. In neonates (premature and full-term), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially under occlusion).

3. How to use Lomexin

Use this medicine exactly as stated in this leaflet or as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Apply Lomexin 1-2 times a day, as directed by your doctor, after washing and drying the affected area, using the formulation appropriate for the location of the lesion.

• Lomexin cream: is indicated for the treatment of hairless skin areas (glabrous skin), skin folds, and mucous membranes. Apply Lomexin cream with gentle rubbing.

Lomexin cream is preferably used for fungal infections that are dry:

• infection known as “pityriasis versicolor”
• skin infection called “erythrasma”
• nail infections (onychomycosis). In these infections, apply the cream under occlusive dressing
• localized infections in male genitals.
  • Lomexin cutaneous spray, solution: is indicated for infections located on the scalp and hairy skin areas, for extensive infections, and for hard-to-reach areas.

Lomexin is non-greasy, does not stain, and can be washed off with water.
Use in children and adolescents
Lomexin contains excipients with known effects that require specific warnings and precautions (see section “Important information on some excipients”).
If you use more Lomexin than you should
In case of accidental ingestion/overdose of Lomexin, contact your doctor immediately or go to the nearest hospital.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.
If you forget to use Lomexin
Do not use a double dose to make up for the missed dose.
If you stop using Lomexin
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
When used as recommended, Lomexin is poorly absorbed and undesirable effects affecting the whole body (systemic effects) are not expected. Prolonged use of topical medicines (local use) may lead to sensitization phenomena (see section "Warnings and precautions").
The following side effects have been observed with Lomexin:
Very rare (may affect up to 1 in 10,000 people)

• redness of the skin (erythema)
• itching
• skin rash
• skin rash and redness (erythematous exanthema)
• skin irritation
• burning sensation of the skin.

Not known (frequency cannot be estimated from the available data)

• hypersensitivity

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly through the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lomexin

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lomexin contains
Lomexin 20 mg/g cream

• The active substance is fenticonazole nitrate. 1 g of cream contains 20 mg of fenticonazole nitrate.
• The other components are propylene glycol, hydrogenated lanolin, refined almond oil, polyglycolyzed fatty acid esters, cetyl alcohol, glyceryl monostearate, sodium edetate, purified water.

Lomexin 20 mg/ml cutaneous spray, solution

• The active substance is fenticonazole nitrate. 1 ml of solution contains 20 mg of fenticonazole nitrate.
• The other components are ethanol, propylene glycol, purified water.

Description of the appearance of Lomexin and the contents of the pack
Lomexin is available as:

• 20 mg/g cream. The pack contains one 30 g tube.
• 20 mg/ml cutaneous spray, solution. The pack contains one 30 ml bottle with spray pump.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milan, Italy.
Marketing Authorisation Holder's representative for sale: INNOVA PHARMA S.p.A. – Milan, Italy.

Manufacturer
Lomexin cream
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milan, Italy.
Vamfarma S.r.l. - via Kennedy, 5 - 26833 Comazzo (LO), Italy.

Lomexin cutaneous spray, solution
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milan, Italy.

Patient information leaflet

Lomexin 2% vaginal cream, 200 mg soft vaginal capsules, 600 mg soft vaginal capsules, 0.2% vaginal solution

fenticonazole nitrate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you to do.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
• Contact your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What Lomexin is and what it is used for
2. What you need to know before using Lomexin
3. How to use Lomexin
4. Possible side effects
5. How to store Lomexin
6. Package contents and other information

1. What Lomexin is and what it is used for

Lomexin contains the active substance fenticonazole nitrate.
It belongs to a group of medicines called "gynaecological antimicrobials and antiseptics".
Lomexin is used to treat infections of the genital mucous membranes caused by a fungus called Candida, such as:

• inflammation of the vulva and vagina (vulvovaginitis)
• inflammation of the cervix (cervicitis)
• increased vaginal discharge due to infection (infectious leucorrhoea).

Consult your doctor if you do not feel better or if you feel worse after a short period of treatment.

2. What you need to know before using Lomexin

Do not use Lomexin

• if you are allergic to fenticonazole or to any of the other ingredients of this medicine (listed in section 6).
• Lomexin 600 mg vaginal soft capsules contain soybean lecithin. If you are allergic to peanuts or soy, do not use this medicine.

Warnings and precautions
Talk to your doctor or pharmacist if:

• You are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• You are using latex barrier contraceptives (see section “Other medicines and Lomexin”). Therefore, you must use alternative precautions during the use of this product.
• You are using spermicides, vaginal douches or other vaginal products (see section “Other medicines and Lomexin”).
• You experience any irritation or sensitivity to the medicine.
• Your symptoms do not improve within one week or if you have severe or recurrent symptoms.
• Your partner is also infected.
• You have had more than two previous infections in the last 6 months.
• You or your partner have ever had a sexually transmitted disease.
• You have ever had hypersensitivity to imidazoles or other vaginal antifungal products.
• You are over 60 years old.
• You have any of the following symptoms:
  • Abnormal or irregular vaginal bleeding.
  • Blood-tinged vaginal discharge.
  • Sores, ulcers or blisters on the vulva or vagina.
  • Lower abdominal pain or difficulty urinating (dysuria).
  • Adverse effects such as redness, itching or rash associated with treatment.

Lomexin vaginal cream: contact with the eyes must be avoided.
Children and adolescents
Lomexin is not recommended for children under 16 years of age.
Other medicines and Lomexin
The fatty excipients and oils contained in the vaginal cream and vaginal soft capsules may damage latex contraceptives, such as condoms and diaphragms (see section “Warnings and precautions”).
The use of spermicides (substances inserted vaginally that destroy sperm and are used as contraceptives alone or in combination, for example with diaphragms) is not recommended. Any local vaginal treatment may inactivate a locally acting contraceptive spermicide.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are breastfeeding, ask your doctor for advice before using this medicine. Lomexin should be used during pregnancy and breastfeeding under medical supervision.
Lomexin vaginal cream: during pregnancy, the applicator must not be used.
Driving and using machines
Lomexin does not affect the ability to drive or operate machinery.
Lomexin vaginal cream contains:

• cetyl alcohol and hydrogenated lanolin which may cause localized skin reactions (e.g. contact dermatitis)
• 50 mg of propylene glycol in 1 g of cream

Lomexin vaginal solution contains:

• 15 g of propylene glycol in 150 ml of solution
• 15 mg of benzalkonium chloride in 150 ml of solution, which may cause local irritation.

Lomexin vaginal soft capsules contain:

• sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate which may cause allergic reactions (including delayed reactions).

3. How to use Lomexin

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

• Lomexin vaginal cream
  The recommended dose is the contents of the applicator (approximately 5 g). Insert the applicator's contents deeply into the vagina (see instructions for use). Apply Lomexin cream using the applicator (which is washable and reusable) before going to bed, and if necessary also in the morning. To avoid reinfection, it is advisable to simultaneously treat the partner locally (glans and foreskin) with Lomexin cream.

Instructions for use:

1. Screw the applicator onto the tube in place of the cap.
2. Gently press the tube at its lower end to fill the applicator. If the plunger offers resistance, pull it gently. Unless otherwise prescribed by the doctor, fill the applicator completely.
3. Remove the applicator from the tube, which should be immediately closed with the cap.
4. While lying down, with knees raised and apart, gently insert the applicator as deeply as possible into the vagina. Push the plunger fully. Then withdraw the applicator without touching the plunger.

Ensure the applicator is always perfectly clean. After each use, wash it thoroughly with warm water and soap. If your doctor has advised you to sterilize the applicator for specific reasons, follow their instructions.
However, do not use water hotter than 50°C, nor organic solvents.
Then dry the applicator and store it in its container.

• Lomexin soft vaginal capsules
  The recommended dose is:
  • 1 soft vaginal capsule of 200 mg in the evening before bedtime for three days, depending on the doctor’s judgment; or
  • 1 soft vaginal capsule of 600 mg as a single evening dose. If symptoms persist, a second dose may be repeated after 3 days.

Instructions for use:
The soft vaginal capsules must be inserted deeply into the vagina (up to the level of the fornices).

• Lomexin vaginal solution
  The recommended dose is 1–2 vaginal irrigations per day for 7 days, as an adjunctive therapy to other formulations for the prevention of recurrences.

Instructions for use:

Fig. 1 Hold the bottle by the knurled ring and bend the cap until the safety seal breaks.
Fig. 2 Remove the cannula by holding it through the cap until it clicks into position.
Fig. 3 The cannula can be oriented as needed. Gently insert the cannula into the vagina and squeeze the sides of the bottle with more or less pressure to completely empty it; a special valve prevents the solution from returning into the bottle.
Perform the irrigation preferably while lying down.
A slow irrigation promotes better medicated cleansing.

Use in children and adolescents
The recommended dose in children aged 16 years and older is the same as in adults.

If you use more Lomexin than you should
If the vaginal capsules, vaginal cream, or vaginal solution are accidentally swallowed or ingested orally, contact your doctor immediately or go to the nearest hospital.

If you forget to use Lomexin
Do not use a double dose to make up for the forgotten dose.

If you stop using Lomexin
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
When the medicine is inserted into the vagina, a slight burning sensation may occur, which will quickly disappear.
When used as recommended, Lomexin is only minimally absorbed and no side effects affecting the whole body (systemic effects) have been reported.
The use of topical medicines, especially if prolonged, may lead to sensitization (see section "Warnings and precautions").
The following side effects have been reported with Lomexin:
Very rare (may affect up to 1 in 10,000 people):

• vulvovaginal burning sensation
• skin redness (erythema), itching, and skin rash.

Frequency not known:

• hypersensitivity at the application site.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lomexin

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lomexin contains
Lomexin 2% vaginal cream

• The active substance is fenticonazole nitrate. 100 g of cream contain 2 g of fenticonazole nitrate.
• The other components are propylene glycol, hydrogenated lanolin, refined almond oil, polyglycolized fatty acid esters, cetyl alcohol, glyceryl monostearate, sodium edetate, purified water.

Lomexin 200 mg vaginal soft capsules

• The active substance is fenticonazole nitrate. Each capsule contains 200 mg of fenticonazole nitrate.
• The other components are saturated fatty acid triglycerides, anhydrous colloidal silica. Capsule shell constituents: gelatin, glycerin, titanium dioxide, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate.

Lomexin 600 mg vaginal soft capsules

• The active substance is fenticonazole nitrate. Each capsule contains 600 mg of fenticonazole nitrate.
• The other components are liquid paraffin, white vaseline, soybean lecithin. Capsule shell constituents: gelatin, glycerin, titanium dioxide, sodium ethyl parahydroxybenzoate, sodium propyl parahydroxybenzoate.

Lomexin 0.2% vaginal solution

• The active substance is fenticonazole nitrate. 100 ml of solution contain 0.2 g of fenticonazole nitrate.
• The other components are propylene glycol, benzalkonium chloride, alkylamidobetaine solution, purified water.

Description of the appearance of Lomexin and package contents
Lomexin is available as:

• 2% vaginal cream. The package contains one 78 g tube with 1 applicator.
• 200 mg vaginal soft capsules. The package contains 6 capsules.
• 600 mg vaginal soft capsules. The package contains 2 capsules.
• 0.2% vaginal solution. The package contains 5 150 ml bottles with single-use applicators.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milan.
Sales Licensee: INNOVA PHARMA S.p.A. – Milan.
Manufacturer
Lomexin vaginal cream
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milan.
Vamfarma S.r.l. - via Kennedy, 5 - 26833 Comazzo (LO).
Lomexin vaginal solution
Special Product’s Line S.p.A. – Via Fratta Rotonda Vado Largo, 1 – 03012 Anagni (FR).
Lomexin vaginal soft capsules
CATALENT ITALY S.p.A. – via Nettunense Km 20,100 – Aprilia (LT).

Package leaflet: Information for the patient

Lomexin 1000 mg vaginal soft capsules

fenticonazole nitrate
Please read this leaflet carefully before using this medicine because it contains important information for you.
Use this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, consult your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if you experience worsening of symptoms after a short period of treatment.

Contents of this leaflet:

1. What Lomexin is and what it is used for
2. What you need to know before using Lomexin
3. How to use Lomexin
4. Possible side effects
5. How to store Lomexin
6. Package contents and other information

1. What Lomexin is and what it is used for

Lomexin contains the active substance fenticonazole nitrate.
It belongs to a group of medicines called "gynaecological antimicrobials and antiseptics".
Lomexin is used to treat the following conditions:

• vaginal infections caused by a microorganism called Trichomonas vaginalis (vaginal trichomoniasis)
• mixed vaginal infections caused by two microorganisms called Trichomonas vaginalis and Candida albicans
• infections of the mucous membranes of the genital organs caused by a fungus called Candida, such as:
  • inflammation of the vulva and vagina (vulvovaginitis)
  • inflammation of the uterine cervix (cervicitis)
  • increased vaginal discharge due to infection (infectious leucorrhoea).

Consult your doctor if you do not feel better or feel worse after a short period of treatment.

2. What you should know before using Lomexin

Do not use Lomexin

• if you are allergic to fenticonazole or to any of the other ingredients of this medicine (listed in section 6).
• Lomexin 1000 mg soft vaginal capsules contain soybean lecithin. If you are allergic to peanuts or soy, do not use this medicine.

Warnings and precautions
Talk to your doctor or pharmacist if:

• You are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).
• You are using latex-based barrier contraceptive methods (see section “Other medicines and Lomexin”). Therefore, you must use alternative precautions during the use of this product.
• You are using spermicides, vaginal douches, or other vaginal products (see section “Other medicines and Lomexin”).
• You experience any irritation or sensitivity to the medicine.
• Your symptoms do not improve within one week or if you have severe or recurrent symptoms.
• Your partner is also infected.
• You have had more than two previous infections in the last 6 months.
• You or your partner have ever had a sexually transmitted infection.
• You have ever had hypersensitivity to imidazoles or other antifungal vaginal products.
• You are over 60 years old.
• You have any of the following symptoms:
  • Abnormal or irregular vaginal bleeding.
  • Blood traces in vaginal discharge.
  • Sores, ulcers, or blisters on the vulva or vagina.
  • Lower abdominal pain or difficulty urinating (dysuria).
  • Adverse effects such as redness, itching, or rash associated with treatment.

Children and adolescents
Lomexin is not recommended for children under 16 years of age.
Other medicines and Lomexin
The fatty excipients and oils contained in the soft vaginal capsules may damage latex-based contraceptives, such as condoms and diaphragms (see section “Warnings and precautions”).
The use of spermicides (substances inserted vaginally that destroy sperm and are used as contraceptives alone or in combination, for example with diaphragms) is not recommended. Any local vaginal treatment may inactivate a locally acting contraceptive spermicide.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, or are breastfeeding, consult your doctor before using this medicine. Lomexin should be used during pregnancy and breastfeeding under the supervision of a doctor.
Driving and using machines
Lomexin does not affect the ability to drive or operate machinery.
Lomexin contains:

• sodium ethyl parahydroxybenzoate and sodium propyl parahydroxybenzoate, which may cause allergic reactions (including delayed reactions).

3. How to use Lomexin

Use this medicine exactly as stated in this leaflet or as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.

For vaginal infections caused by Trichomonas and mixed infections (Trichomonas and Candida), the recommended dose is:

• 1 soft vaginal capsule of 1000 mg, followed by a second application after 24 hours, if necessary.

For infections caused by Candida, the recommended dose is:

• 1 soft vaginal capsule of 1000 mg at bedtime as a single dose. If symptoms persist, a second dose may be repeated after 3 days.

Instructions for use:

Soft vaginal capsules should be inserted deeply into the vagina (as far as the fornices).
Use in children and adolescents
The recommended dose for children aged 16 years and older is the same as for adults.
If you use more Lomexin than you should
If the vaginal capsules are accidentally taken orally or swallowed, contact your doctor immediately or go to the nearest hospital.
If you forget to use Lomexin
Do not use a double dose to make up for the missed dose.
If you stop using Lomexin
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
When the medicine is inserted into the vagina, a slight burning sensation may occur, which will disappear quickly.
When used as recommended, Lomexin is only minimally absorbed and no side effects affecting the whole body (systemic effects) have been reported.
The use of topical medicines, especially if prolonged, may lead to sensitization (see section "Warnings and precautions").
The following side effects have been reported with Lomexin:
Very rare (may affect up to 1 in 10,000 people):

• vulvovaginal burning sensation
• skin redness (erythema), itching, and skin rash.

Frequency not known:

• hypersensitivity at the application site.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lomexin

This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “Exp”. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Lomexin contains

• The active substance is fenticonazole nitrate. Each capsule contains 1000 mg of fenticonazole nitrate.
• The other ingredients are liquid paraffin, white vaseline, soybean lecithin. Components of the capsule shell: gelatin, glycerin, titanium dioxide, sodium ethyl p-hydroxybenzoate, sodium propyl p-hydroxybenzoate.

Description of the appearance of Lomexin and package contents
Lomexin is available as soft vaginal capsules of 1000 mg. The pack contains 2 capsules.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
RECORDATI Industria Chimica e Farmaceutica S.p.A. – via Matteo Civitali, 1 – 20148 Milan, Italy.
Sales Licensee: INNOVA PHARMA S.p.A. – Milan.
Manufacturer
CATALENT ITALY S.p.A. – via Nettunense Km 20,100 – Aprilia (LT), Italy.