Scholmed 10 mg/g cream
Spain
Table of Contents
- Patient Information Leaflet
- Introduction
- 1. What Scholmed 10 mg/g cream is and what it is used for
- 2. What you need to know before using Scholmed 10 mg/g Cream
- 3. How to use Scholmed 10 mg/g Cream
- 4. Possible adverse effects
- 5. Storage of Scholmed 10 mg/g Cream
- 6. Contents of the pack and other information
Patient Information Leaflet
Introduction
Patient Information Leaflet
Scholmed 10 mg/g Cream
Terbinafine hydrochloride
Read the entire 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 those given by your doctor or pharmacist.
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Package leaflet:
- What Scholmed 10 mg/g Cream is and what it is used for
- What you need to know before using Scholmed 10 mg/g Cream
- How to use Scholmed 10 mg/g Cream
- Possible side effects
- How to store Scholmed 10 mg/g Cream
- Contents of the pack and other information
1. What Scholmed 10 mg/g cream is and what it is used for
Terbinafine is an antifungal drug belonging to the allylamine class, which works by preventing the growth of fungi.
This medicine is indicated for the treatment of tinea pedis (athlete's foot) in adults, a superficial fungal skin infection located between the toes.
The main symptoms are: itching, redness (erythema), cracking between the toes, and scaling, which may progress to inflammation or pustules.
You should consult a doctor if your condition worsens or does not improve after 7 days of treatment.
2. What you need to know before using Scholmed 10 mg/g Cream
Do not use Scholmed 10 mg/g Cream
If you are allergic to terbinafine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before starting to use Scholmed
- This medicine is for topical use only and specifically for athlete's foot. It may be irritating to the eyes, so contact with the eyes should be avoided. In case of accidental contact, rinse thoroughly with tap water.
- Avoid any contact with the eyes or areas near the eyes, as well as with mucous membranes.
- If you experience any reaction at the application site, you may need to discontinue treatment. Consult your doctor if this occurs.
- Treatment should always be accompanied by proper personal hygiene and appropriate clothing due to the risk of reinfection. It is recommended to wear well-ventilated shoes, avoid rubber shoes and soles, avoid fiber socks, and change socks with each application.
- To prevent transmission, do not share towels, socks, or footwear with others, and avoid walking barefoot in pools, changing rooms, and communal bathrooms.
Children and adolescents:
Experience with the use of terbinafine in children is limited; therefore, its use is not recommended in individuals under 18 years of age.
Using Scholmed 10 mg/g Cream with other medicines:
Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.
The simultaneous use of other products on the areas where terbinafine cream is applied is not recommended.
Pregnancy, breastfeeding and fertility:
If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 effect of this medicine on the ability to drive and use machines is none or negligible.
Scholmed 10 mg/g Cream contains 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 for this medicine provided in this leaflet or as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
This medicine is for topical use only on the affected skin areas of the feet.
The recommended dose for adults over 18 years of age is: one or two applications per day, for 7 days.
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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.
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Remember to use your medicine regularly.
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It is advisable to wear well-ventilated shoes, avoid rubber shoes and soles, avoid synthetic fiber socks, and change socks with each application to prevent reinfection. To avoid transmission, do not share towels, socks, or footwear with other people, and do not walk barefoot in swimming pools, locker rooms, or communal bathrooms.
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If after 7 days of use you do not observe an improvement in your symptoms, consult your doctor.
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If you have any further questions about the use of this product, consult your doctor or pharmacist.
If you use more Scholmed 10 mg/g Cream than you should:
If you have used more cream than recommended, consult your doctor or pharmacist. In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 91 562 04 20.
If you forget to use Scholmed 10 mg/g Cream:
If you forget to apply the cream, apply it as soon as you remember. However, if it is almost time for the next dose, wait until then. Never use a double amount of cream to make up for a forgotten dose.
If you stop using Scholmed 10 mg/g Cream:
Do not interrupt treatment with Scholmed 10 mg/g Cream before 7 days, as the infection may recur.
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 may produce adverse effects, although not everyone experiences them.
Uncommon adverse effects (affecting between 1 and 10 out of every 1000 people) are: irritation or burning sensation at the application site.
Adverse effects with unknown frequency (frequency cannot be estimated from available data):
- Allergic reactions (hypersensitivity) such as skin rashes or urticaria, and in rare cases erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis.
- Pruritus, erythema, burning sensation of the skin.
- Irritation at the application site.
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 via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse 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 container 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 medicines and their containers at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Scholmed 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 pack contents:
White, shiny, uniform cream. It is supplied in a container containing 15 grams of cream.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Scholl Wellness Company B.V., Luna Arena, Herikerbergweg 238, 1101 CM Amsterdam, The Netherlands
Manufacturer: LABORATORIOS LICONSA S.A.
Avda. Miralcampo nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara), SPAIN
For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:
Vemedia Pharma Hispania, S.A.
C/ Aragón, 182, 5th floor
08011 - Barcelona
Spain
Date of the most recent revision of this leaflet: March 2021
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicinal Products and Medical Devices (AEMPS) http://www.aemps.gob.es/