Lomexin 600 mg soft vaginal capsule

Patient Information Leaflet

Introduction

Patient Information Leaflet

Lomexin 600 mg Soft Vaginal Capsule

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 those given by your pharmacist.

• Keep this leaflet, as you may need to read it again.
• If you need advice or further information, consult your pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
• You should consult a doctor if your condition worsens or if you do not improve after 3 days.

Leaflet Contents

1. What Lomexin 600 mg Soft Vaginal Capsule is and what it is used for
2. What you need to know before using Lomexin 600 mg Soft Vaginal Capsule
3. How to use Lomexin 600 mg Soft Vaginal Capsule
4. Possible adverse effects
5. How to store Lomexin 600 mg Soft Vaginal Capsule
6. Contents of the pack and other information

1. What Lomexin 600 mg soft vaginal capsule is and what it is used for

Lomexin 600 mg soft vaginal capsule belongs to a group of medicines called gynecological anti-infectives and antiseptics.

Lomexin 600 mg contains fenticonazole, which is an antifungal (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) (See section Warnings and precautions).

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

You should consult a doctor if symptoms worsen or do not improve after 3 days.

2. What you need to know before using Lomexin 600 mg soft vaginal capsule

Do not use Lomexin 600 mg soft vaginal capsule

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

Warnings and precautions

Before using this medicine, inform your doctor if you have a weakened immune system, for example, if you are receiving oral corticosteroid treatment 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.

Consult your doctor or pharmacist before starting to use Lomexin 600 mg soft vaginal capsule:

• 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 medicine

• if symptoms worsen during treatment or persist beyond 3 days, or in case of severe recurrent symptoms

• if your partner is also affected

• if you have had more than two previous infections within the last 6 months

• if you or your partner have had a sexually transmitted infection

• if you have had hypersensitivity to imidazoles or other vaginal antifungal medicines

• if you are over 60 years of age

• 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 upon urination or other urinary problems associated with vaginal discharge

• foul-smelling vaginal discharge

Children and adolescents

Lomexin is not recommended for girls under 16 years of age.

Other medicines and Lomexin 600 mg soft vaginal capsule

The oils and fatty excipients contained in the soft vaginal capsule formulation 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, e.g., 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 might be pregnant, or plan to become pregnant, consult your doctor before using this medicine. The use of Lomexin should be under medical supervision during pregnancy and breastfeeding.

Driving and using machines

The effect of Lomexin 600 mg soft vaginal capsule on the ability to drive and operate machinery is negligible or none.

Lomexin 600 mg soft vaginal capsule contains ethyl parahydroxybenzoate, sodium salt (E 215) and propyl parahydroxybenzoate, sodium salt (E 217)

It may cause allergic reactions (possibly delayed) because it contains ethyl parahydroxybenzoate, sodium salt (E 215) and propyl parahydroxybenzoate, sodium salt (E 217).

3. How to use Lomexin 600 mg soft vaginal capsule

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

Lomexin vaginal capsules are for vaginal use only. Do not swallow.

The vaginal capsule should be inserted as deeply as possible into the vagina at bedtime.

The recommended dose is:

• One vaginal capsule (single dose). If symptoms persist, consult your doctor.

Use in children and adolescents

The recommended dose for children aged 16 years and older is the same as that for adults.

If you use more Lomexin 600 mg soft vaginal capsule than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service. Telephone: 91 562 04 20, stating the name of the medicine and the amount used or accidentally ingested.

If you forget to use Lomexin 600 mg soft vaginal capsule

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

If you stop using Lomexin 600 mg soft vaginal capsule

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 everyone experiences them.

A mild burning sensation may occur when the medicine is inserted into the vagina, which rapidly disappears. When used as recommended, systemic absorption of Lomexin is negligible, and no adverse effects in the rest of the body (systemic effects) have been reported.

The topical use of this medicine, especially if prolonged, may lead to sensitization (see section “Warnings and precautions”).

The following adverse effects have been reported with Lomexin:

Very rare (affects less than 1 patient in 10,000)

• vulvovaginal burning sensation
• cutaneous erythema, pruritus, and rash

Frequency not known:

• hypersensitivity at the application site

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: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lomexin 600 mg soft vaginal capsule

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 packaging. The expiry date is the last day of the month indicated.

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

6. Contents of the pack and other information

Composition of Lomexin 600 mg soft vaginal capsule

• The active substance is fenticonazole nitrate. Each vaginal capsule contains 600 mg of fenticonazole nitrate.

• The other components are:

Excipients in the core: liquid paraffin, soft white paraffin, soybean lecithin.

Excipients in the capsule shell: gelatin, glycerol (E 422), titanium dioxide (E 171), ethyl parahydroxybenzoate sodium salt (E 215), propyl parahydroxybenzoate sodium salt (E 217).

Presentation of the product and contents of the pack

Lomexin 600 mg is presented as a soft vaginal capsule, white–ivory in colour, in a PVC/aluminum blister pack, in packaging containing 1 soft vaginal capsule.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Casen Recordati, S.L.,

Autovía de Logroño, km 13.300

50180 Utebo, Zaragoza (Spain)

Manufacturer

Catalent Italy, S.P.A.

Via Nettunense, Km 20,100

Aprilia (LT) 04011

Italy

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

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