Clotrimazole Nutra Essential 10 mg/g cutaneous foam

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ClotrimazolNutra Essential 10 mg/g cutaneous foam

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

Follow exactly the instructions for use provided in this leaflet or as directed by your doctor or pharmacist.

• Keep this leaflet as you may need to read it again.
• If you need advice or more information, consult your pharmacist.
• If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.

- You must consult a doctor if your condition worsens or does not improve after 10 days.

Contents of this leaflet

1. What Clotrimazol Nutra Essential 10 mg/g cutaneous foam is and what it is used for
2. What you need to know before using Clotrimazol Nutra Essential 10 mg/g cutaneous foam
3. How to use Clotrimazol Nutra Essential 10 mg/g cutaneous foam
4. Possible adverse effects
5. How to store Clotrimazol Nutra Essential 10 mg/g cutaneous foam
6. Contents of the pack and other information

1. What Clotrimazole Nutra Essential 10 mg/g Cutaneous Foam Is and What It Is Used For

Clotrimazole is an antifungal (a medicine used to treat infections caused by fungi).

It is indicated for the treatment of athlete's foot, which is a superficial fungal infection of the skin occurring between the toe folds.

The main symptoms of athlete's foot are itching, redness (erythema), cracks between the toes, scaling, and possibly inflammation or pustules. It occurs only on the feet. It usually begins between the toes but may also spread to the soles and sides of the feet.

You should consult your doctor if your condition worsens or does not improve after 10 days of treatment.

2. What you need to know before using Clotrimazol Nutra Essential 10 mg/g cutaneous foam

Do not use Clotrimazol Nutra Essential 10 mg/g cutaneous foam:

• if you are allergic (hypersensitive) to clotrimazole, to imidazoles in general, or to any of the other components of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Clotrimazol Nutra Essential 10 mg/g cutaneous foam.

• Do not apply non-breathable dressings over the affected area.

• Consult your doctor if irritation develops at the treated site and discontinue treatment.

• Do not ingest.

• This medicine should be applied only to the skin and exclusively for the treatment of athlete's foot.

• Discontinue treatment if symptoms do not improve after 10 days of treatment.

• Avoid contact with eyes and mucous membranes. If accidental contact occurs, rinse thoroughly with water and consult an ophthalmologist if necessary.

• It is advisable to wear well-ventilated shoes, avoid rubber shoes and soles, avoid synthetic fiber socks, and change socks with each application.

• Adequate hygiene measures should be followed to prevent transmission: do not share towels, socks, or footwear, and avoid walking barefoot in pools, locker rooms, and public bathrooms.

Children and adolescents

Use in children under 12 years of age only under medical supervision.

Other medicines and Clotrimazol Nutra Essential 10 mg/g cutaneous foam

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

Pregnancy and breastfeeding

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

Pregnancy

Adequate and well-controlled studies in humans during the first trimester of pregnancy have not been conducted. Animal studies have not shown adverse effects on the fetus; however, because animal reproduction studies are not always predictive of human response, this drug should be used during the first trimester of pregnancy only if clearly needed.

Breastfeeding

It is not known whether clotrimazole, when used topically, is excreted in human breast milk. However, no problems have been reported in humans.

Driving and use of machines

The influence of clotrimazole on the ability to drive and operate machinery is none or negligible.

Warnings about excipients

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

This medicine may cause skin irritation because it contains propylene glycol.

3. How to use Clotrimazol Nutra Essential 10 mg/g Cutaneous Foam

Follow exactly the instructions for use provided in this leaflet or those given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.

For topical use only.

Recommended dose:

Apply once to the affected area of the feet 2–3 times daily. The treatment should last for 3 to 4 weeks.

Apply and spread a small amount of the product to completely cover the affected area and surrounding skin, paying special attention to the folds between the toes. Rub in gently until fully absorbed.

A strip of cutaneous foam approximately 2 cm long is sufficient to treat an area the size of the hand (dorsal and palmar surfaces). As a guide, 2 cm corresponds to the length of the distal phalanx of the index finger.

To prevent relapses of these infections, it is recommended to continue treatment for an additional 2 weeks after all symptoms have disappeared.

Instructions for using the cutaneous foam: for correct application, follow these steps:

1. Before applying the product, wash the feet with water and soap to remove skin scales and any residue from previous treatments. After washing, dry thoroughly, especially the interdigital spaces.
2. Hold the container upside down and press the nozzle to dispense the foam onto the fingertips.
3. Apply a small amount of the product and spread it to completely cover the affected area and surrounding skin until fully absorbed, especially between the toe folds.
4. Close the container tightly after use.
5. Wash your hands after each application.

It is advisable to wear well-ventilated shoes, avoid shoes and rubber soles, avoid synthetic fiber socks, and change socks with each application to reduce the risk of reinfection. To prevent transmission, do not share towels, socks, or footwear with others, and avoid walking barefoot in swimming pools, locker rooms, and public restrooms. Hand washing after each application is recommended.

If after 10 days of use you do not observe improvement in your symptoms, consult your doctor.

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

Use in children and adolescents

Use in children under 12 years of age only under medical supervision. Dose adjustment is not required.

If you use more Clotrimazol Nutra Essential 10 mg/g cutaneous foam than you should

Due to the concentration of active ingredient and the route of administration of Clotrimazol Nutra Essential 10 mg/g cutaneous foam, acute intoxication requiring specific treatment is not expected, even in the unlikely event of accidental ingestion.

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

If you forget to use Clotrimazol Nutra Essential 10 mg/g cutaneous foam

If you miss a dose, wait until the next scheduled dose. Do not apply a double dose to make up for the missed dose.

If you stop using Clotrimazol Nutra Essential 10 mg/g cutaneous foam

If you interrupt the treatment, the fungi may not be fully eradicated. If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse reactions with unknown frequency (cannot be estimated from available data) include:

Immune system disorders:

Allergic reactions: syncope (sudden loss of consciousness, fainting), hypotension (low blood pressure), breathing difficulty, urticaria (raised, red, itchy rash).

Skin and subcutaneous tissue disorders:

Blisters, discomfort/pain, edema, erythema, pruritus, burning/itching sensation, irritation, exfoliation (skin peeling), and skin rash.

These symptoms usually do not require discontinuation of treatment and are more frequent during the first days of treatment.

Reporting of 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 leaflet. You may also report them directly through the national reporting system available at www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Clotrimazole Nutra Essential 10 mg/g Cutaneous Foam

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

Pressurized container. Do not pierce or throw into fire, even when it appears to be empty.

Protect from direct sunlight and excessive heat.

Store below 30°C. Do not freeze.

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 should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their containers. This will help protect the environment.

6. Contents of the package and other information

Composition of ClotrimazolNutra Essential 10 mg/g cutaneous foam

• The active substance is clotrimazole 10 mg.
• The other components (excipients) are: cetyl alcohol, glycerol monostearate, macrogol lauryl ether, macrogol cetyl stearyl ether, propylene glycol, benzyl alcohol, anhydrous sodium hydrogen phosphate, potassium dihydrogen phosphate, N-butane and purified water.

Appearance of the product and contents of the container

Cutaneous foam containing 30 g of product.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Farmalider, S.A.

C/ La Granja, 1, 3rd floor

28108 Alcobendas – Madrid, Spain

Manufacturer

FARMALIDER, S.A

C/ Aragoneses, 2

28108 Alcobendas

Madrid

Date of the most recent review of this leaflet: September 2017

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