SCHOLMED 10 mg/g CREAM

Introduction

Package Leaflet: Information for the User

Scholmed10 mg/g Cream

Terbinafine Hydrochloride

Contents of the package leaflet:

1. What is Scholmed 10 mg/g Cream and what is it used for
2. What you need to know before you start using Scholmed 10 mg/g Cream
3. How to use Scholmed 10 mg/g Cream
4. Possible side effects
5. Storage of Scholmed 10 mg/g Cream
6. Contents of the pack and further information

1. What is Scholmed 10 mg/g cream and what is it used for

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

This medicine 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 scaling, which can lead to inflammation or pus.

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

2. What you need to know before you start using Scholmed 10 mg/g Cream

Do not useScholmed 10 mg/g Cream

If you are allergic to terbinafine or any of the other components of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or pharmacist before starting to use Scholmed

• This medicine is for use on the skin only and exclusively for athlete's foot. It can be irritating to the eyes, so contact with them should be avoided. In case of accidental contact, they should be thoroughly rinsed with tap water.
• Any contact with the eyes or areas close to them, as well as with mucous membranes, should be avoided.
• If after administration you experience any reaction in the treated area, you may need to interrupt treatment. Consult your doctor if this is the case.
• Treatment should always be accompanied by measures of body hygiene and adequate clothing due to the possibility of reinfection. It is recommended to use well-ventilated shoes, avoid rubber shoes and soles, avoid fiber socks, and change socks with each application.
• To avoid contagion, towels, socks, or shoes should not be shared with other people, and you should not walk barefoot in swimming pools, locker rooms, and collective bathrooms.

Children and adolescents:

Experience with the use of terbinafine in children is limited, so its use is not recommended in minors under 18 years of age.

Use ofScholmed 10 mg/g Creamwith other medicines:

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

The use of other products in the areas where the terbinafine cream is applied is not recommended at the same time.

Pregnancy, breastfeeding, and fertility:

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

Do not use this medicine if you are breastfeeding, as terbinafine and its metabolites pass into breast milk.

Driving and using machines:

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

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

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

This medicine contains 10 mg of benzyl alcohol in each gram of cream. Benzyl alcohol may cause allergic reactions. Benzyl alcohol may cause moderate local irritation.

3. How to use Scholmed 10 mg/g Cream

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

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

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

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

• Remember to use your medicine.

• 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 shoes with other people, and do not walk barefoot in swimming pools, locker rooms, and collective bathrooms.

• 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 Toxicology Information Service. Phone 91 562 04 20.

If you forget to useScholmed 10 mg/g Cream

If you forget to apply the cream, apply it as soon as you remember, although if it is close to the next application, it is best to wait until then. You should never use a double amount of cream to make up for the forgotten dose.

If you interrupt treatment withScholmed 10 mg/g Cream

Do not interrupt treatment with Scholmed 10 mg/g Cream before 7 days, as it is possible that the infection may reappear.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Uncommon side effects (affecting between 1 and 10 in every 1000 people) are: irritation or burning sensation at the application site.

Frequency not known side effects (cannot be estimated from the available data):

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

Reporting of side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Scholmed 10 mg/g Cream

No special storage conditions are required.

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

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

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicine in the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and further information

Composition ofScholmed 10 mg/g Cream:

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

Appearance of the product and contents of the pack:

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

Marketing authorization holder and 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 medicine by contacting the local representative of the marketing authorization holder:

Vemedia Pharma Hispania, S.A.

C/ Aragón, 182, 5ª planta

08011 - Barcelona

Spain

Date of the last revision of this leaflet: March 2021

Detailed information about this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/