Label: information for the user

ClotrimazolNutra Essential10 mg/g topical cream

Read this label carefully before starting to use this medication, as it contains important information for you

Follow exactly the medication administration instructions contained in this label or those indicated by your doctor or pharmacist.

- Keep this label, as you may need to refer to it again.

- If you need advice or more information, consult your pharmacist.

- If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

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

1.What is Clotrimazol Nutra Essential 10 mg/g topical cream and what is it used for

2.What you need to know before starting to use Clotrimazol Nutra Essential 10 mg/g topical cream

3.How to use Clotrimazol Nutra Essential 10 mg/g topical cream

4.Possible adverse effects

5.Storage of Clotrimazol Nutra Essential 10 mg/g topical cream

6.Contents of the package and additional information

Clotrimazol 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 skin infection caused by fungi and located between the toes.

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

Do not use ClotrimazolNutra Essential 10 mg/g topical cream:

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

Warnings and precautions

Consult your doctor or pharmacist before starting to useClotrimazolNutra Essential 10 mg/g topical cream.

• Do not apply non-breathable dressings over the affected area.
• Consult your doctor if irritation occurs in the treated area and discontinue treatment.
• Do not ingest

• Apply the medication only on 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 the eyes and mucous membranes. If accidental contact with the eyes occurs, rinse with plenty of water and consult an ophthalmologist if necessary.
• It is recommended to use well-ventilated shoes, avoid rubber shoes and soles, avoid cotton socks, and change socks after each application.
• Appropriate hygiene measures should be followed to prevent contagion, do not share towels, socks, footwear, or walk barefoot in pools, locker rooms, and public bathrooms.

Children and adolescents

Use in children under 12 years old under medical supervision.

Other medications and Clotrimazol Nutra Essential 10 mg/g topical cream

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

Pregnancy and lactation

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

Pregnancy

No adequate and well-controlled studies have been conducted in humans during the first trimester of pregnancy. Animal studies have not demonstrated adverse effects on the fetus, however, due to the unpredictability of animal reproduction studies in humans, this medication will only be administered if clearly indicated during the first trimester of pregnancy.

Lactation

The excretion of clotrimazol in breast milk is unknown. However, no problems have been described in humans.

Driving and operating machinery

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

Warnings about excipients

This medication may cause local skin reactions (such as contact dermatitis) due to the presence of cetyl alcohol.

This medication may cause skin irritation due to the presence of propylene glycol.

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

Skin use.

The recommended dose is:

One application on 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 between the toes of the feet. Rub until complete absorption.

A strip ofskin cream, approximately 2 cm long, is sufficient to treat an area the size of a hand (back and palm). As a guide, 2 cm is equivalent to the length of the last phalanx 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 theskin cream: for a correct application, follow the steps indicated:

1. Before applying the product, wash the feet with water and soap to remove scales and any remaining residue from the last treatment. After washing, dry thoroughly, especially between the toes.
2. Hold the bottle 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 the surrounding area until complete absorption, especially between the toes of the feet.
4. Close the container well after use.
5. Wash your hands after each application.

It is recommended to use well-ventilated shoes, avoid rubber shoes and soles, avoid cotton socks, and change socks after each application due to the possibility of re-infection. To avoid contagion, do not share towels, socks, or footwear with others, and do not walk barefoot in pools, locker rooms, and public baths. 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 questions about the use of this product, ask your doctor or pharmacist.

Skin use in children and adolescents

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

If you use moreClotrimazol Nutra Essential10 mg/g skin creamthan you should

Given the concentration of active principle and the application route of the Clotrimazol Nutra Essential 10 mg/g skin cream preparation, there is no possibility of acute poisoning that requires special treatment, not even in the unlikely event of accidental ingestion.

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

If you forgot to useClotrimazolNutra Essential10 mg/g skin cream

In case of forgotten dose, wait for the next one. Do not apply a double dose to compensate for the missed dose.

If you interrupt treatment withClotrimazolNutra Essential10 mg/g skin cream

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

Like all medications,this medicationmay cause adverse effects, although not all people will experience them.

Unknown frequency reactions (cannot be estimated from available data) without:

Immune system disorders:

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

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 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 national notification system included inwww.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Pressurized container. Do not pierce or burn, even when apparently empty.

Protect from direct sunlight and excessive heat.

Store below 30°C. Do not freeze.

Do not usethis medicationafter the expiration date that appears on the container after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and medicines you no longer need at the SIGRE collection pointof the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help protect the environment.”

Composition of ClotrimazoleNutra Essential10 mg/g topical cream

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

Appearance of the product and contents of the packaging

Topical cream containing 30 g of product.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Nutra Essential OTC, S.L.

C/ La Granja, 1, 3rd floor

28108 Alcobendas - Madrid

Responsible for manufacturing

FARMALIDER, S.A

C/ Aragoneses, 2

28108 Alcobendas

Madrid

Last review date of this leaflet: September 2017

“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/”