LAMISIL 10 mg/g CUTANEOUS SPRAY SOLUTION

Introduction

Package Leaflet: Information for the User

Lamisil 10 mg/g cutaneous spray solution

terbinafine hydrochloride

Read the package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Lamisil and what is it used for
2. What you need to know before using Lamisil
3. How to use Lamisil
4. Possible side effects
5. Storage of Lamisil
6. Package contents and additional information

1. What is Lamisil and what is it used for

Lamisil is an antifungal medication for use on the skin. It works by preventing the growth of fungi that cause skin problems.

Lamisil is used to treat:

• Athlete's foot (Tinea pedis)
• Fungal skin infection of the groin area, known as Tinea cruris
• Fungal skin infection that affects any part of the body, known as Tinea corporis
• Yeast infection of the skin, known as pityriasis versicolor.

2. What you need to know before using Lamisil

Do not use Lamisil:

• if you are allergic to terbinafine or any of the other ingredients of this medication (listed in section 6 and at the end of section 2).

Tell your doctor or pharmacist if this is the case and do not use this medication.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Lamisil.

• Children under 18 years of ageshould not use Lamisil. In newborns (premature and full-term babies), high concentrations of ethanol may cause severe local reactions and systemic toxicity due to significant absorption through the immature skin (especially in case of occlusion).
• Do not use the solution on the faceor on areas where the skin is cut or inflamed, where the alcohol (ethanol) may be irritating.
• Lamisil contains alcohol. Flammable product. Avoid using it near a flame, lit cigarettes, or certain devices (e.g., hair dryers).
• For external use only. Do not use it in the mouth or swallow it.
• Avoidcontactwith the eyes, as it may be irritating to them. If the medication accidentally comes into contact with your eyes, rinse them thoroughly with plenty of water and consult your doctor if any discomfort persists.

Other medications and Lamisil

• Do not apply other medications or treatments to the affected area(including those purchased without a prescription) at the same time as Lamisil.

• Tell your doctor or pharmacistif you are using, have recently used, or may need to use any other medication, including those purchased without a prescription.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medication. Lamisil should not be used during pregnancy unless strictly necessary.

Do not use Lamisil while breastfeeding.

Children who are breastfed should be kept away from any treated skin area, including the breast.

Driving and using machines

Using this medication does not affect your ability to drive or use machines.

Important information about some of the ingredients of Lamisil cutaneous spray solution

This medication contains 48.54 mg of propylene glycol in each milliliter of cutaneous spray solution. It also contains 6.83 g of alcohol (ethanol) in each package, which is equivalent to 227.8 mg/ml. It may cause a burning sensation on damaged skin.

3. How to use Lamisil

Follow the administration instructions for this medication exactly as indicated by your doctor. If you are unsure, consult your doctor or pharmacist again.

How long to use Lamisil

Apply the cutaneous spray solution to the affected area once or twice a day, as indicated below, unless your doctor tells you otherwise.

• Tinea pedis(athlete's foot): once a day for one week.
• Tinea crurisand Tinea corporis: once a day for one week.
• Pityriasis versicolor: twice a day for one week.

Instructions for use

Follow these instructions carefully:

• Clean and dry the affected skin areas and surrounding areas, and wash your hands.
• Remove the cap and gently squeeze the bottle.
• Apply enough solution to moisten the affected skin area and surrounding area completely.
• Replace the cap on the bottle.
• Wash your hands after using the solution; otherwise, you may spread the infection to other areas of your skin or to others.

If after one week of treatment with Lamisil there are no signs of improvement, consult your doctor or pharmacist.

Discard any remaining solution12 weeks after first opening.

To help the treatment

Keep the affected skin area clean, washing it regularly. Dry it carefully with gentle patting and without rubbing. Try not to scratch the area, even if you feel itching, as this may harm you and slow down the healing process or spread the infection.

Since these infections can be easily transmitted to others, remember to use your own towel and clothes and not share them with anyone. To protect yourself from reinfection, wash your clothes and towels frequently.

If you use more Lamisil than you should

If you have accidentally ingested some of the product, inform your doctor immediately, who will tell you what to do.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91 562 04 20.

If you forget to use Lamisil

If you forget to apply the cutaneous spray solution, apply it as soon as you remember, and then continue with the next dose at the usual time. If you remember at the time of the next application, just apply the normal amount and continue with the usual schedule.

Do not apply a double dose to make up for forgotten doses.

Use the cutaneous spray solution as indicated. This is important, as the infection may recur if you forget several applications.

If you stop using Lamisil

Apply this medication until you complete the recommended treatment period, even if the infection seems to improve after a few days. The infection may recur if you stop the treatment too early.

If you have any further questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

STOP using Lamisil and seek medical help immediatelyif you experience any of the following symptoms, which may be signs of an allergic reaction:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue, or throat
• severe skin itching, with a red rash or appearance of bumps

Some side effects are common(may affect up to 1 in 10 patients)

skin peeling, itching.

Some side effects are uncommon(may affect up to 1 in 100 patients)

skin injury, crust formation, skin disorder, changes in skin color, skin redness (erythema), burning, pain, pain at the application site, irritation at the application site.

Some side effects are rare(may affect up to 1 in 1,000 patients)

skin dryness, rash and itching (contact dermatitis), redness and burning (eczema).

eye irritation.

worsening of skin condition.

Other side effects reported(frequency not known)

allergic reaction (hypersensitivity)

rash

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use (www.notificaRAM.es). By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lamisil

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

Do not use this medication after the expiration date stated on the package after CAD. The expiration date is the last day of the month indicated.

Do not store above 30°C. Do not refrigerate.

Replace the cap on the bottle after use. Discard any remaining solution 12 weeks after first opening.

Medications should not be disposed of through wastewater or household waste. Deposit the packages and medications you no longer need at the SIGRE collection point in your pharmacy. If you have any questions, ask your pharmacist how to dispose of packages and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Lamisil 10 mg/g cutaneous spray solution

• The active ingredient is terbinafine hydrochloride. One gram of Lamisil cutaneous spray solution contains 10 mg of terbinafine hydrochloride, equivalent to 8.8 mg of terbinafine base.
• The other ingredients are: purified water, ethanol (23.5% w/w), propylene glycol (E-1520), cetostearyl ethanol.

Appearance of the product and package contents

Lamisil cutaneous spray solution is a clear, colorless to slightly yellowish liquid. It is available in 30 ml bottles.

Marketing authorization holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona

Spain

Manufacturer

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona

Spain

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg

Germany

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

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona

Spain

Date of the last revision of this package leaflet:March 2022

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