Lomexin 20 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lomexin 20 mg/g cream

fenticonazole nitrate

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Follow exactly the instructions for use provided in this leaflet or as indicated by your pharmacist.

• Keep this leaflet, as you may need to read it again.

• If you need advice or more information, consult your pharmacist.

• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

• You should consult a doctor if your condition worsens or if you do not improve after 7 days.

Contents of the leaflet

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

1. What Lomexin Cream Is and What It Is Used For

Lomexin 20 mg/g cream belongs to a group of medicines called topical antifungal agents, specifically imidazole and triazole derivatives.

Lomexin 20 mg/g cream contains fenticonazole, an antifungal agent (a medicine used to treat infections caused by fungi). This medicine is indicated for the treatment of uncomplicated vulvovaginal candidiasis (a vaginal infection caused by a fungus called Candida) in combination with Lomexin soft vaginal capsules (see section Warnings and Precautions).

The main symptoms include itching, usually accompanied by increased vaginal discharge, pain and redness in the vaginal and vulvar areas, and burning or a burning sensation during urination. These symptoms are not specific to vulvovaginal candidiasis. If in doubt, consult your doctor.

2. What you need to know before using Lomexin cream

Do not use Lomexin cream

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

Warnings and precautions

Before using this medicine, inform your doctor if you have a weakened immune system, for example, if you are being treated with oral corticosteroids or if you have HIV infection, AIDS, or diabetes. These patient groups often experience complicated infections that do not respond well to short-term treatments.

Avoid contact with the eyes. If accidental contact occurs, rinse thoroughly with plenty of water.

After application of Lomexin, a transient mild burning sensation may occur, which usually disappears quickly.

Consult your doctor or pharmacist before starting to use Lomexin cream:

• If you are pregnant or breastfeeding (see section “Pregnancy, breastfeeding and fertility”).

• If you are using a latex barrier contraceptive method (see section “Other medicines and Lomexin”). Therefore, you should take additional contraceptive measures while using this medicine.

• If you are using spermicides, vaginal douches, or other vaginal products (see section “Other medicines and Lomexin”).

• If you experience irritation or sensitivity to the product. In general, sensitization or allergic reactions may occur with prolonged use of topical (locally applied) products.

• If you have had more than two previous infections in the last 6 months.

• If your symptoms do not improve within one week, or in case of severe or recurrent symptoms.

• If your partner is also affected.

• If you or your partner have ever had a sexually transmitted infection.

• If you have ever had hypersensitivity to imidazoles or other vaginal antifungal products.

• If you have any of the following symptoms:

• Abnormal or irregular vaginal bleeding

• Blood spotting in vaginal discharge

• Vulvar or vaginal sores, ulcers, or blisters

• Lower abdominal pain or dysuria

• Adverse effects such as redness, itching, or rash associated with treatment

• High fever (38 °C or higher)

• Back pain

• Nausea

• Burning during urination or other urinary problems associated with vaginal discharge

• Foul-smelling vaginal discharge

Other medicines and Lomexin cream

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions have been reported with the use of this medicine.

The oils and fatty excipients contained in the topical cream may damage latex-based barrier 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 a contraceptive method 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 or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Since there is no experience with use during pregnancy and breastfeeding, Lomexin should not be used during these periods unless, in the opinion of the physician, the benefit to the patient justifies the potential risks.

Driving and use of machines

The effect of Lomexin on the ability to drive and operate machinery is none or negligible.

Lomexin contains Propylene glycol

Propylene glycol may cause skin irritation.

Lomexin contains lanolin and cetyl alcohol

This medicine may cause local skin reactions (such as contact dermatitis) because it contains lanolin and cetyl alcohol.

3. How to use Lomexin cream

Follow exactly the instructions for use provided in this leaflet or those indicated by your pharmacist. If in doubt, ask your doctor or pharmacist.

Lomexin 20 mg/g cream is indicated as an adjunct to gynecological treatment with Lomexin soft vaginal capsule in vulvovaginal candidiasis (a fungal gynecological infection affecting the vulva and/or vagina), for the local treatment of skin conditions of the vulva (vulvitis).

It should be applied with gentle rubbing onto the affected area, ensuring to include approximately 1 cm of surrounding healthy skin.

The cream should be applied after washing and drying the affected area, once daily, preferably at night, for up to seven days.

Symptom relief should begin within three days of treatment. If you do not observe improvement after seven days, you should consult your doctor.

If you use more Lomexin cream than you should

Due to the low concentration of active substance and the route of administration, intoxication is very unlikely.

In case of overdose or accidental ingestion, contact the Toxicology Information Service immediately at telephone: 91 562 04 20, stating the medication and the amount ingested.

If you forget to use Lomexin cream

Do not use a double dose to make up for forgotten doses.

If you stop using Lomexin cream

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.

Lomexin is generally well tolerated when applied to the skin and mucous membranes. When used as recommended, the amount of Lomexin absorbed into the bloodstream is negligible, so the occurrence of systemic adverse effects affecting the whole body can be ruled out.

Consult your doctor or pharmacist if any of the adverse effects worsen or if you experience any adverse effects not listed below:

Very rare adverse effects (may affect up to 1 in 10,000 patients)

Erythema

Pruritus

Rash

Erythematous rash

Skin irritation

Burning sensation in the skin

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lomexin cream

No special storage conditions are required.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

After opening, Lomexin cream can be used for 30 days following the first opening of the tube. After opening, store below 25°C.

6. Contents of the pack and other information

Composition of Lomexin cream

• The active substance is fenticonazole nitrate. Each gram of cream contains 20 mg of fenticonazole nitrate.

• The other components are propylene glycol (E-1520), hydrogenated lanolin, sweet almond oil, polyethylene glycol esters of fatty acids, cetyl alcohol, glycerol monostearate, sodium edetate, purified water.

Appearance of the product and contents of the pack

Lomexin 20 mg/g cream is presented as a homogeneous ivory-white cream in an enamelled aluminium tube with a screw cap made of HDPE or PP, containing 30 g of cream.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Casen Recordati, S.L.,

Autovía de Logroño, km 13.300

50180 Utebo, Zaragoza (Spain)

Manufacturer

Recordati industria chimica e farmaceutica, S.p.A.

Via Matteo Civitali, 1

20148 – Milan - Italy.

or

Vamfarma S.R.L.

Via Kennedy, 5.

26833 Comazzo (Lodi) - Italy

Date of the most recent revision of this leaflet: March 2026

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)