LOMEXIN 20 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Lomexin 20 mg/g Cream

fenticonazole nitrate

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Lomexin cream is and what it is used for
2. What you need to know before you use Lomexin cream
3. How to use Lomexin cream
4. Possible side effects

5 Storage of Lomexin cream

1. Contents of the pack and further 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 antifungals, imidazole and triazole derivatives.

It is indicated for the local treatment of vulvitis (inflammation of the vulva) and balanitis (inflammation of the glans penis) caused by an infection caused by a fungus called Candida.

It is also indicated as a complementary treatment for the partner of infected women.

2. What you need to know before you use 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

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

• after applying Lomexin, a transient sensation of burning, of a mild nature, may occur, which usually disappears quickly.

• if there is no improvement in symptoms, you should consult your doctor, who will suspend treatment and perform the necessary tests to confirm the diagnosis before repeating the treatment.

• in case of allergic reactions, you should stop treatment and consult your doctor. In general, sensitization or allergic reactions can occur when using topical products (local application) for a prolonged period.
• avoid contact with the eyes, in case this occurs, wash them abundantly with water.

Other medicines and Lomexin cream

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

Driving and using machines

Lomexin has no or negligible influence on the ability to drive and use machines.

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 administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Lomexin 20 mg/g cream is indicated as a complement to gynecological treatment with Lomexin vaginal soft capsule in vulvovaginal candidiasis (gynecological infection caused by fungi, affecting the vulva and/or vagina), for the local treatment of skin conditions in the vulva (vulvitis) as well as in candidal balanitis (inflammation of the glans penis caused by a fungal infection) of the partner.

It should be applied with a gentle rubbing motion over the lesion, trying to cover about 1 cm (approximately) of healthy skin around the affected area.

The cream should be applied after washing and drying the affected area, once a day, preferably at night, or, in case of severe infection, 2 times a day (morning and night).

Applications should be made regularly until complete healing of the lesions (2 to 4 weeks).

If you use more Lomexin cream than you should

Given the low concentration of active ingredient and the route of administration, it is very unlikely that an overdose will occur.

In case of overdose or accidental ingestion, consult the Toxicology Information Service immediately, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Lomexin cream

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

If you stop using Lomexin cream

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The use of Lomexin is generally well tolerated when applied to the skin and mucous membranes. When used as recommended, the amount of Lomexin that passes into the blood is insignificant, and therefore the possibility of side effects that affect the whole body can be ruled out.

Consult your doctor or pharmacist if any of the side effects get worse or if you experience any side effect not listed below:

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

Erythema

Pruritus

Rash

Erythematous rash

Skin irritation

Burning sensation on the skin

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es/. By reporting side 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 which is stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

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

6. Contents of the pack and further information

Composition of Lomexin cream

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

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

Appearance of the product and contents of the pack

Lomexin 20 mg/g cream is presented as a homogeneous cream of ivory white color in an aluminum tube with an HDPE or PP screw cap containing 30 g of cream.

Marketing authorization holder and manufacturer

Marketing authorization 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

This leaflet was approved in April 2021

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/)