Leaflet: information for the user

Scholmed10 mg/g Cream

Terbinafine hydrochloride

Terbinafine is an antifungal medication, belonging to the group of allylamines, which acts by preventing the growth of fungi.

This medication is indicated for the treatment of tinea pedis or athlete's foot in adults, a superficial skin infection caused by fungi and located between the toes.

The main symptoms are: itching, redness (erythema), cracks between the toes, and peeling, which may lead to inflammation or pustules.

You should consult a doctor if it worsens or does not improve after 7 days of treatment.

No useScholmed 10 mg/g Cream

If you are allergic to terbinafine 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 Scholmed

• This medication is only for use on the skin and exclusively for athlete's foot. It may be irritating to the eyes, so it should be avoided. In the event of accidental contact, the affected area should be thoroughly washed with tap water.
• Avoid any contact with the eyes or areas close to them, as well as mucous membranes.
• If you experience any reaction in the treated area after administration, you may need to discontinue treatment. Consult your doctor if this is the case.
• Treatment should always be accompanied by proper hygiene and suitable clothing, as reinfection is possible. It is recommended to use well-ventilated shoes, avoid rubber shoes and soles, avoid cotton socks, and change socks after each application.
• To prevent contagion, do not share towels, socks, or footwear with others, and do not walk barefoot in public pools, locker rooms, and bathrooms.

Children and adolescents:

The experience of using terbinafine in children is limited, so it is not recommended for use in individuals under 18 years old.

Use ofScholmed 10 mg/g Creamwith other medications:

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

It is not recommended to use other products in the same area where the terbinafine cream is applied at the same time.

Pregnancy, lactation, and fertility:

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using any medication. This medication should not be used during pregnancy unless clearly indicated.

Do not use this medication while breastfeeding, as terbinafine and its metabolites pass into breast milk.

Driving and operating machinery:

The influence of this medication on the ability to drive and operate machinery is negligible.

Scholmed 10 mg/g Creamcontains cetomacrogol, benzyl alcohol, and stearyl alcohol.

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

This medication contains 10 mg of benzyl alcohol per gram of cream. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause moderate local irritation.

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

This medication should be used exclusively on the skin of the affected area of the feet.

The recommended dose for adults over 18 years is: one or two applications per day, for 7 days.

• Before applying the cream, clean and dry the affected areas carefully. Apply a thin layer of cream to the affected skin between the toes of the feet, and gently massage until completely absorbed.

• Remember to use your medication.

• It is recommended to use well-ventilated shoes, avoid rubber shoes and soles, avoid fiber 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 other people, and do not walk barefoot in pools, locker rooms, and public baths.

• If after 7 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.

If you use moreScholmed 10 mg/g Creamthan you should:

If you have used more cream than you should, consult your doctor or pharmacist. In case of overdose or accidental ingestion, consult the Toxicological Information Service. Phone 91 562 04 20.

If you forgot to useScholmed 10 mg/g Cream

If you forgot to apply the cream, apply it as soon as you remember, although if there is little time left for the next application, it is best to wait until then. Never use double the amount of cream to compensate for the missed dose.

If you interrupt treatment withScholmed 10 mg/g Cream

Do not interrupt treatment withScholmed 10 mg/g Creambefore 7 days, as it is possible that the infection will recur.

If you have any other doubts 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.

The less common adverse effects (affecting between 1 and 10 out of every 1,000 people) are: irritation or a burning sensation at the application site.

The adverse effects of unknown frequency (cannot be estimated from available data):

• Allergic reactions (hypersensitivity) such as skin rashes or urticaria and in rare cases, Stevens-Johnson syndrome and toxic epidermal necrolysis.
• Pruritus, erythema, burning sensation on the skin.
• Irritation at the application site.

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:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

This product does not require special conditions for conservation.

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

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 down the drains or in the trash.Deposit the packaging and medications that you no longer need at the SIGRE Point of the pharmacy.Please ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition ofScholmed 10 mg/g Cream:

• The active ingredient is hydrochloride of terbinafine. Each gram of cream contains 10 mg of hydrochloride of terbinafine.
• The other components (excipients) are benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polisorbate 60, isopropyl myristate, sodium hydroxide, and purified water.

Appearance of the product and contents of the packaging:

Bright, uniform, and white cream. It is presented in a container containing 15 grams of cream.

Holder of the marketing authorization and responsible manufacturer

Holder:

Scholl Wellness Company B.V., Luna Arena, Herikerbergweg 238, 1101 CM Amsterdam, Netherlands

Manufacturer:LABORATORIOS LICONSA S.A.

Avda. Miralcampo nº 7 Polígono Industrial Miralcampo

19200 Azuqueca de Henares (Guadalajara), SPAIN

You can request more information about this medication by contacting the local representative of the holder of the marketing authorization:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5th floor

08011 - Barcelona

Spain

Last review date of this leaflet: March 2021

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