Laurimic 20 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Laurimic 20 mg/g cream

Fenticonazole nitrate

Read the entire 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Laurimic cream is and what it is used for
2. What you need to know before using Laurimic cream
3. How to use Laurimic cream
4. Possible adverse effects
5. How to store Laurimic cream
6. Contents of the pack and other information

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

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

Laurimic cream is indicated for:

• Cutaneous candidiasis (intertrigo, angular cheilitis, facial candidiasis, diaper candidiasis, perineal and scrotal candidiasis), balanitis, balanopostitis, onychia, and paronychia.
• Dermatophytoses caused by dermatophytes (Trichophyton, Microsporum, and Epidermophyton) at various sites: tinea capitis, tinea corporis, tinea cruris, tinea pedis (athlete's foot), tinea manuum, tinea faciei, tinea barbae, tinea unguium.
• Pityriasis versicolor due to Pityrosporum orbiculare and P. ovale.
• Otitis externa caused by Candida and molds, solely in the absence of tympanic membrane perforation.
• Erythrasma.
• Fungal infections with bacterial superinfections due to Gram-positive bacteria.

2. What you need to know before using Laurimic cream

Do not use Laurimic cream

• if you are allergic to fenticlozole nitrate or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

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

• After applying Laurimic cream, a mild, transient burning sensation may occur, which usually disappears quickly.
• If there is no improvement in symptoms, you should consult your doctor, who will stop treatment and perform the necessary tests to confirm the diagnosis before restarting treatment.
• If allergic-type reactions occur, discontinue treatment and consult your doctor. In general, sensitization or allergic reactions may occur when topical (locally applied) products are used for prolonged periods.
• Avoid contact with the eyes. If contact occurs, rinse thoroughly with plenty of water.

Other medicines and Laurimic cream

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

As 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 opinion of the physician, the benefit to the patient outweighs the potential risks.

Driving and using machines

The effect of Laurimic cream on the ability to drive and operate machinery is none or negligible.

Laurimic cream contains propylene glycol (E 1520),

Propylene glycol may cause skin irritation.

Laurimic contains hydrogenated 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 Laurimic cream

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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

It should be applied with gentle rubbing onto the affected area, making sure to include approximately 1 cm of surrounding healthy skin. The cream should be applied after washing and drying the affected area, once or twice daily, preferably at night or both morning and night.

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

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

If you use more Laurimic cream than you should

Due to the low concentration of the active substance and the route of administration, intoxication is highly unlikely.

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

If you forget to use Laurimic cream

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

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 may cause adverse effects, although not everyone experiences 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 absorbed into the bloodstream is negligible, thus ruling out the possibility of systemic adverse effects affecting the whole body.

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 in the skin

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es/. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Laurimic 20 mg/g cream

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

Store below 25°C.

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines must not be disposed of via wastewater or household waste. Dispose of empty containers and unused medicines at the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the package and other information

Composition of Laurimic 20 mg/g cream

• The active substance 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 contents of the pack

Laurimic 20 mg/g cream is a homogeneous, off-white cream contained in an enamelled aluminium tube with a net content of 30 g.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 most recent revision of this package leaflet: 08/2009

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/