Terbinafine Combix 10 mg/g cream EFG
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Terbinafine Combix 10 mg/g cream EFG
Read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
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Package leaflet contents:
- What Terbinafina Combix is and what it is used for
- What you need to know before using Terbinafina Combix
- How to use Terbinafina Combix
- Possible side effects
- Storage of Terbinafina Combix
Contents of the pack and other information
1. What Terbinafine Combix is and what it is used for
Terbinafine is an antifungal drug belonging to the allylamine class, which works by preventing fungal growth.
This medicine is used to treat the following superficial skin infections:
- Tinea pedis, Tinea cruris, and Tinea corporis (caused by a type of fungi known as dermatophytes).
- Cutaneous candidiasis (caused by yeasts of the genus Candida).
- Pityriasis (tinea) versicolor.
2. What you need to know before using Terbinafina Combix
Do not use Terbinafina Combix
If you are allergic to terbinafine or to any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Consult your doctor or pharmacist before starting to use Terbinafina Combix.
- This medicine is for topical use only. It may be irritating to the eyes, so contact must be avoided. In case of accidental contact, rinse thoroughly with tap water.
- If you experience any reaction at the application site after administration, you may need to discontinue treatment. Consult your doctor if this occurs.
Using Terbinafina Combix with other medicines
Inform your doctor or pharmacist if you are taking, have recently taken, 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 and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Do not use this medicine if you are breastfeeding, as terbinafine passes into breast milk.
Use in children
Experience with terbinafine in children is limited; therefore, its use is not recommended.
Driving and using machines
This medicine does not affect your ability to drive or operate machinery.
Important information about some of the ingredients of Terbinafina Combix 10 mg/g cream
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.
3. How to use Terbinafina Combix
This medicine is for external use only.
Always follow exactly the instructions for use provided by your doctor. If in doubt, consult your doctor again.
The cream may be applied once or twice daily for one week (for the treatment of Tinea pedis, Tinea cruris, Tinea corporis, and cutaneous candidiasis) or for two weeks (for the treatment of pityriasis versicolor). Your doctor will determine the duration of your treatment.
Before applying the cream, clean and dry the affected areas thoroughly. Apply a thin layer of cream to the affected skin and surrounding areas, and gently massage. If the infection is located between the fingers or toes, under the breasts, or in the groin area, it is advisable to cover the area with gauze, especially at night.
Remember to use your medicine as directed.
If you use more Terbinafina Combix than you should
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.
If you forget to use Terbinafina Combix
If you forget to apply the cream, apply it as soon as you remember. However, if it is almost time for the next application, wait until then. Never use a double amount of cream to make up for a missed dose.
If you stop using Terbinafina Combix
Do not stop treatment with Terbinafina Combix cream before the time indicated by your doctor, as the infection may recur.
If you have any further questions about the use of this product, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everybody will experience them.
Uncommon adverse effects, affecting 1 or more of every 1,000 patients but fewer than 100, who receive this medicine are: irritation or burning sensation at the application site.
Very rare adverse effects, affecting fewer than 1 in every 10,000 patients receiving this medicine, occur in the skin and in the tissue beneath it, and include: allergic reactions, itching, urticaria, and blistering.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.
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 through the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Terbinafina Combix
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date stated on the carton after EXP. The expiry date is the last day of the month indicated.
Medicines must not be disposed of via wastewater or household waste. Unused medicines and waste materials should be handed over to the SIGRE point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of unused medicines and their containers. This will help protect the environment.
6. Contents of the pack and other information
Composition of Terbinafina Combix 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 (E1519), sorbitan monostearate (E491), cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60 (E435), isopropyl myristate, sodium hydroxide (E524) and purified water.
Appearance of the product and contents of the container
Terbinafina Combix 10 mg/g cream is shiny, uniform and white in colour. It is supplied in containers containing 30 g of cream.
Marketing Authorization Holder:
Laboratorios Combix, S.L.U.
C/ Badajoz 2, Edificio 2
28223 Pozuelo de Alarcón (Madrid)
Spain
Manufacturer:
LABORATORIOS LICONSA, S.A.
Avda. Miralcampo, Nº 7, Polígono Industrial Miralcampo
19200 Azuqueca de Henares (Guadalajara)
Spain
Date of the most recent revision of this leaflet: January 2007
Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.