LAURIMIC 20 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Laurimic 20 mg/g Cream

Fenticonazole Nitrate

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Laurimic cream is and what it is used for
2. What you need to know before starting to use Laurimic cream
3. How to use Laurimic cream
4. Possible side effects
5. Storage of Laurimic cream
6. Package contents and additional information

1. What Laurimic cream is and what it is used for

Laurimic cream belongs to a group of medications called topical antifungals, imidazole and triazole derivatives.

Laurimic cream is indicated for:

• dermal candidiasis (intertrigo, thrush, facial candidiasis, "diaper" candidiasis, perineal and scrotal candidiasis), balanitis, balanoposthitis, onychia, and paronychia.
• dermatomycoses caused by dermatophytes (Trichophyton, Microsporum, and Epidermophyton) with different locations: tinea capitis, tinea corporis, tinea cruris, tinea pedis (athlete's foot), tinea manuum, tinea faciei, tinea barbae, tinea unguium.
• pityriasis versicolor caused by Pityrosporum orbiculareand P. ovale
• otomycosis caused by Candidaand molds, only in the absence of tympanic membrane perforation.
• erythrasma.
• mycoses with bacterial superinfections caused by Gram-positive bacteria.

2. What you need to know before starting to use Laurimic cream

Do not use Laurimic cream

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

Warnings and precautions

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

• After applying Laurimic, a transient burning sensation, usually mild, 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 treatment.
• In case of allergic reactions, you should discontinue treatment and consult your doctor. In general, sensitization or allergic reactions can occur when using topical products (local application) for prolonged periods.
• Avoid contact with the eyes; if this occurs, rinse them thoroughly with water.

Other medications and Laurimic cream

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

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

Pregnancy and breastfeeding

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

Since there is no experience with the use of Laurimic cream during pregnancy and breastfeeding, it 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

Laurimic cream has no significant influence on the ability to drive and use machines.

Laurimic cream contains propylene glycol (E 1520),

Propylene glycol may cause skin irritation.

Laurimic cream contains hydrogenated lanolin and cetyl alcohol

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

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3. How to use Laurimic cream

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist again.

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

Laurimic 20 mg/g cream is used in the treatment of hairless skin, skin folds, and mucous membranes.

It should be applied with gentle rubbing 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 or twice a day, preferably at night or morning and night.

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

Laurimic 20 mg/g cream is also used in the treatment of dry mycosis: pityriasis versicolor, erythrasma, and onychomycosis (in onychomycosis, an occlusive dressing should be applied).

If you use more Laurimic cream than you should

Given the low concentration of the 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 medication and the amount ingested.

If you forget to use Laurimic cream

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

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

Consult your doctor or pharmacist if any of the side effects worsen 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 side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: https://www.notificaram.es/. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Laurimic 20 mg/g cream

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

Store below 25°C.

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

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

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and medications you no longer need at the SIGRE point in the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Laurimic 20 mg/g cream

• The active ingredient is fenticonazole nitrate. Each gram of cream contains 20 mg of fenticonazole nitrate.
• The other components are: almond oil, purified water, cetyl alcohol, sodium edetate, polyethylene glycol esters of fatty acids, hydrogenated lanolin (E 913), glycerol monostearate, and propylene glycol (E 1520).

Appearance of the product and package contents

Laurimic 20 mg/g cream is presented as a homogeneous cream with an ivory-white color in an aluminum tube, containing 30 g of cream.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Laboratorios Effik, S.A.

C/ San Rafael, 3

28108 Alcobendas (Madrid)

Manufacturer:

ITALFARMACO S.A.

C/ San Rafael, 3

28108 Alcobendas (Madrid)

Date of the last revision of this package leaflet:08/2009

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