CLOTRIMAZOL NUTRA ESSENTIAL 10 mg/g CUTANEOUS FOAM

Introduction

Package Leaflet: Information for the User

ClotrimazoleNutra Essential10 mg/g Cutaneous Foam

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly.

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

You should consult a doctor if it worsens or does not improve after 10 days.

Contents of the Package Leaflet

1. What Clotrimazole Nutra Essential 10 mg/g Cutaneous Foam is and what it is used for
2. What you need to know before starting to use Clotrimazole Nutra Essential 10 mg/g Cutaneous Foam
3. How to use Clotrimazole Nutra Essential 10 mg/g Cutaneous Foam
4. Possible side effects
5. Storage of Clotrimazole Nutra Essential 10 mg/g Cutaneous Foam
6. Package Contents and Additional Information

1. What Clotrimazole Nutra Essential 10 mg/g Cutaneous Foam is and what it is used for

Clotrimazole is an antifungal (a medication used to treat fungal infections).

It is indicated for the treatment of "athlete's foot", which is a superficial skin infection caused by fungi and located between the folds of the toes.

The main symptoms of athlete's foot are: itching, redness (erythema), cracks between the toes, scaling that can lead to inflammation or pustules. It only appears on the feet. It usually starts between the toes, but can also spread to the sole and sides of the feet.

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

2. What you need to know before starting to use Clotrimazole Nutra Essential 10 mg/g Cutaneous Foam

Do not use ClotrimazoleNutra Essential 10 mg/g Cutaneous Foam:

• if you are allergic (hypersensitive) to clotrimazole, imidazoles in general, 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 Clotrimazole Nutra Essential 10 mg/g Cutaneous Foam.

• Do not apply non-breathable bandages over the affected area.
• Consult your doctor if irritation appears in the treated area and interrupt treatment.
• Do not ingest

• You should apply the medication only to the skin and exclusively for the treatment of athlete's foot.
• You should suspend treatment if symptoms do not improve after 10 days of treatment.
• Avoid contact with the eyes and mucous membranes. If accidental contact with the eyes occurs, wash with plenty of water and consult an ophthalmologist if necessary.
• It is recommended to use well-ventilated shoes, avoid rubber shoes and soles, avoid fiber socks, and change socks with each application.
• Adequate hygiene measures should be taken to avoid contagion, do not share towels, socks, or footwear, and do not walk barefoot in swimming pools, locker rooms, and collective bathrooms.

Children and Adolescents

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

Other Medications and Clotrimazole Nutra Essential 10 mg/g Cutaneous Foam

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

Pregnancy

Adequate and well-controlled studies have not been conducted in humans during the first trimester of pregnancy. Animal studies have not shown that it produces adverse effects on the fetus; however, since animal reproduction studies are not always predictive of human response, this medication will be administered only if clearly indicated during the first trimester of pregnancy.

Breastfeeding

It is not known if clotrimazole, for cutaneous use, is excreted in breast milk. However, no problems have been described in humans.

Driving and Using Machines

The influence of clotrimazole on the ability to drive and use machines is nil or insignificant.

Warnings about Excipients

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

This medication may produce skin irritation because it contains propylene glycol.

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

Follow the administration instructions for the medication contained in this package leaflet or as indicated by your doctor or pharmacist exactly. In case of doubt, ask your doctor or pharmacist.

Cutaneous use.

The recommended dose is:

One application to the affected area of the feet 2-3 times a day. Treatment should last 3 to 4 weeks.

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

A strip of cutaneous foam, approximately 2 cm, is sufficient to treat an area the size of the hand (back and palm). As a guide, 2 cm is equivalent to the length of the last phalange of the index finger.

To avoid relapses in these infections, it is recommended to continue treatment for 2 weeks after all symptoms have disappeared.

Recommendations for the use of the cutaneous foam: for correct application, follow the indicated steps:

1. Before applying the product, wash your feet with water and soap to remove skin scales and any remaining treatment. After washing, dry thoroughly, especially the interdigital spaces.
2. Hold the bottle upside down and press the nozzle to dispense the foam onto your fingertips.
3. Apply a small amount of the product and spread it to completely cover the affected area and the area around the infection until completely absorbed, especially between the folds of the toes.
4. Close the package well after use.
5. Wash your hands after each application.

It is recommended to use well-ventilated shoes, avoid rubber shoes and soles, avoid fiber socks, and change socks with each application due to the possibility of reinfection. To avoid contagion, do not share towels, socks, or footwear with others, and do not walk barefoot in swimming pools, locker rooms, and collective bathrooms. It is recommended to wash your hands after each application.

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

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

Use in Children and Adolescents

Use in children under 12 years of age under medical supervision. No dose adjustment is required.

If you use moreClotrimazole Nutra Essential10 mg/g Cutaneous Foamthan you should

Given the concentration of the active ingredient and the route of administration of Clotrimazole Nutra Essential 10 mg/g Cutaneous Foam, there is no possibility of acute intoxication that requires special treatment, even in the unlikely event of ingestion of the medication.

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

If you forget to useClotrimazole Nutra Essential 10 mg/g Cutaneous Foam

In case of forgetting a dose, wait for the next one. Do not apply a double dose to make up for the forgotten dose.

If you interrupt treatment withClotrimazoleNutra Essential10 mg/g Cutaneous Foam

If you interrupt treatment, the fungi may not have disappeared. If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, this medication can produce side effects, although not all people experience 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), difficulty breathing, urticaria (elevated red itchy patches).

Skin and Subcutaneous Tissue Disorders:

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

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

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 national reporting system included in www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

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

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

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

Protect from direct sunlight and excessive heat.

Store below 30°C. Do not freeze.

Do not use this medication after the expiration date shown on the package 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 packages and medications you no longer need in the SIGRE Point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packages and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of ClotrimazoleNutra Essential10 mg/g Cutaneous Foam

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

Appearance of the Product and Package Contents

Cutaneous foam for use containing 30 g of product.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Nutra Essential OTC, S.L.

C/ La Granja, 1, 3rd floor

28108 Alcobendas - Madrid

Manufacturer

FARMALIDER, S.A

C/ Aragoneses, 2

28108 Alcobendas

Madrid

Date of the Last Revision of this Package Leaflet: September 2017

"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/"