Lomexin 200 mg soft vaginal capsules

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lomexin 200 mg vaginal soft capsules

Fenticonazole nitrate

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

Follow exactly the instructions for administration of the medicine contained in this leaflet or those 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 adverse effects, consult your doctor or pharmacist, even if they are adverse 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.

Contents of the leaflet

1. What Lomexin 200 mg vaginal soft capsules are and what they are used for
2. What you need to know before using Lomexin 200 mg vaginal soft capsules
3. How to use Lomexin 200 mg vaginal soft capsules
4. Possible adverse effects
5. Storage of Lomexin 200 mg vaginal soft capsules
6. Contents of the pack and other information

1. What Lomexin 200 mg soft vaginal capsules are and what they are used for

Lomexin 200 mg soft vaginal capsules belong to a group of medicines called gynecological anti-infectives and antiseptics.

Lomexin 200 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 an increase in vaginal discharge, pain and redness in the vaginal and vulvar areas, burning, and a burning sensation when urinating. 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 200 mg soft vaginal capsules

Do not use Lomexin 200 mg soft vaginal capsules:

• if you are allergic to fenticonazole nitrate or to 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.

Consult your doctor or pharmacist before using Lomexin 200 mg soft vaginal capsules:

• 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 your 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 to other vaginal antifungal medicines

• if you are over 60 years old

• if you experience 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

Children and adolescents

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

Other medicines and Lomexin 200 mg soft vaginal capsules

The oils and fatty excipients contained in the formulation of the soft vaginal capsules may damage latex-based contraceptive methods, 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 are planning 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 influence of Lomexin 200 mg soft vaginal capsules on the ability to drive and use machines is none or negligible.

Lomexin 200 mg soft vaginal capsules contain Ethyl parahydroxybenzoate, sodium salt (E 215) and Propyl parahydroxybenzoate, sodium salt (E 217)

May cause allergic reactions (possibly delayed) as it contains Ethyl parahydroxybenzoate, sodium salt (E 215) and Propyl parahydroxybenzoate, sodium salt (E 217).

3. How to use Lomexin 200 mg soft vaginal capsules

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 before going to bed.

The recommended dose is:

• One 200 mg vaginal capsule for three consecutive days. If symptoms persist, consult your doctor.

Use in children and adolescents

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

If you use more Lomexin 200 mg soft vaginal capsules than you should

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

If you forget to use Lomexin 200 mg soft vaginal capsules

Do not use a double dose to make up for a missed dose.

If you stop using Lomexin 200 mg soft vaginal capsules

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 can cause adverse effects, although not everyone will experience them.

A mild burning sensation may occur when the medicine is inserted into the vagina; this rapidly disappears. When used as recommended, systemic absorption of Lomexin is negligible, and adverse effects elsewhere in the body (systemic effects) have not been reported.

The use of topical medicinal products, 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 in 10,000 people):

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

Frequency not known:

Hypersensitivity at the site of application.

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

5. Storage of Lomexin 200 mg Soft Vaginal Capsules

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

6. Contents of the pack and other information

Composition of Lomexin 200 mg soft vaginal capsules

• The active substance is fenticonazole nitrate. Each vaginal capsule contains 200 mg of fenticonazole nitrate.

• The other components are:

Excipients in the core: medium-chain triglycerides, colloidal silica.

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).

Appearance of the product and contents of the pack

Lomexin 200 mg is presented as white to ivory-coloured soft vaginal capsules, packed in PVC/aluminum blisters, in packs containing 3 soft vaginal capsules.

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 revision of this leaflet: March 2026

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