Leaflet: information for the user

Lomexin 20 mg/g cream

fenticonazole nitrate

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

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

• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.

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

5Storage of Lomexin cream

1. Contents of the pack and additional information

Lomexin 20 mg/g cream belongs to a group of medicines called topical antifungals, imidazolic and triazolic derivatives.

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

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

Do not use Lomexin cream

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

Warnings and precautions

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

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

• if your symptoms do not improve, you should consult your doctor, who will suspend treatment and perform the necessary tests to confirm the diagnosis before repeating treatment.

• in case of allergic reactions, you should suspend treatment and consult your doctor. Generally, sensitization or allergic reactions can occur when using topical products for an extended period.

• avoid contact with your eyes; if this occurs, wash them abundantly with water.

Other medications and Lomexin cream

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Since there is no experience with use during pregnancy and breastfeeding, Lomexin should not be used in these periods, unless a medical professional determines that the benefits for the patient outweigh the possible risks.

Driving and operating machines

The influence of Lomexin on the ability to drive and operate machines is negligible or insignificant.

Lomexin contains Propylene Glycol

Propylene glycol may cause skin irritation.

Lomexin contains lanolin and cetyl alcohol

This medication may cause local skin reactions (such as contact dermatitis) due to the presence of lanolin and cetyl alcohol.

Follow exactly the administration instructions for this medication as 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 soft vaginal capsule in vulvovaginal candidiasis (gynecological infection caused by fungi, affecting the vulva and/or vagina), for the local treatment of skin conditions on the vulva (vulvitis) as well as in balanitis candidiásica (inflammation of the glans penis caused by a fungal infection) of the partner.

It should be applied with a light rubbing motion over the affected area, making sure to cover approximately 1 cm of healthy skin around the affected area.

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

The applications should be performed regularly until the 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 administration route, it is very unlikely that an overdose will occur.

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

If you forgot to use Lomexin cream

Do not take a double dose to compensate for the missed doses.

If you interrupt the treatment with Lomexin cream

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience 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 adverse effects affecting the entire body can be excluded.

Consult your doctor or pharmacist if any of the adverse effects worsen or if you experience any adverse effect 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 on the Skin

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use: https://www.notificaram.es/. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

No special storage conditions are required.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point of the pharmacy. Ask your pharmacist how to dispose of the containers and unused medicines. In this way, you will help protect the environment.

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

Composition of Lomexin cream

• The active ingredient 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, glyceryl monostearate, sodium edetate, purified water.

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Casen Recordati, S.L.,

Autovía de Logroño, km 13.300

50180 UTEBO. Zaragoza (Spain)

Responsible for manufacturing

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

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)(http://www.aemps.gob.es/)