Package Insert: Information for the User

Laurimic 20 mg/g Cream

Fenticonazole Nitrate

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

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

Laurimic cream belongs to a group of medications called topical antifungals, derived from imidazolic and triazolic compounds.

Laurimic cream is indicated for:

• dermatophyte skin infections (intertrigo, thrush, facial candidiasis, diaper rash, perineal and scrotal candidiasis) balanitis, balanoposthitis, onychomycosis, and paronychia.
• dermatophytosis caused by dermatophytes (Trichophyton,Microsporum, andEpidermophyton) with different locations: tinea capitis, tinea corporis, tinea cruris, athlete's foot (tinea pedis), tinea manuum, tinea faciei, tinea barbae, and tinea unguium.
• pitiriasis versicolor caused byPityrosporum orbiculareandP. ovale
• otomycosis caused byCandidaand molds, only in the absence of tympanic membrane perforation.
• erythrasma.
• mycoses with bacterial superinfections due to Gram-positive bacteria.

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 mild, transient 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 the 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 thoroughly with water.

Other medications and Laurimic 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, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Since there is no experience of use during pregnancy and lactation, Laurimic cream 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 machinery

The influence of Laurimic on the ability to drive and operate machinery is negligible or insignificant.

Laurimic cream contains propylene glycol (E 1520),

Propylene glycol may cause skin irritation.

Laurimic 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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Follow exactly the administration instructions for this medication as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again.

Laurimic 20 mg/g cream is indicated as a complement to gynecological treatment with Laurimic 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.

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

It should be applied with a gentle rubbing motion over the affected area, making sure to cover approximately 1 cm (about) 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 in the morning and at night.

Applications should be performed regularly until the 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, a occlusive dressing should be applied).

If you use more Laurimic cream than you should

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

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

If you forgot to use Laurimic cream

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

If you have any other questions 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 Laurimic cream is generally well tolerated when applied to the skin and mucous membranes. When used as recommended, the amount of Laurimic that enters the bloodstream 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

Exanthema

Erythematous Exanthema

Dermatitis

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.

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 that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be thrown into the drains or trash. Dispose of the containers and medications you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

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), glyceryl monostearate, and propylene glycol (E 1520).

Appearance of the product and contents of the packaging

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

Effik Laboratories, S.A.

C/ San Rafael, 3

28108 Alcobendas (Madrid)

Responsible for manufacturing:

ITALFARMACO S.A.

C/ San Rafael, 3

28108 Alcobendas (Madrid)

Last review date of this leaflet:08/2009

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