Label: Information for the User

Lamisil 10 mg/g topical solution

terbinafine hydrochloride

Read this label carefully before starting to use this medication, because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribedonlyfor you, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label. See section4.

Lamisil is anantifungal agent intended for use on the skin. It acts by preventing the development of fungi causing skin problems.

Lamisil is used to treat:

• athlete's foot (Tinea pedis)
• skin infection caused by fungi located in the groin area, known asTinea cruris
• skin infection caused by fungi affecting any part of the body, known asTinea corporis
• skin infection caused by yeast, known as pityriasis versicolor.

Do not use Lamisil:

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

Inform 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 babies and full-term babies), high concentrations of ethanol can cause severe local reactions and systemic toxicity due to significant absorption through immature skin (especially in cases of occlusion).
• Do not use the solution on the faceoron areas where the skin is cut or inflamed, where alcohol (ethanol) could be irritating.
• Lamisil contains alcohol. Flammable product. Avoid using it near a flame, lit cigarettes, or some devices (e.g., hair dryers).
• For external use only. Do not use in the mouth or swallow.
• Avoidcontactwith the eyesas it may be irritating to them.If the medication accidentally enters your eyesrinse them well 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.

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be 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.

Avoid having children who are breastfeeding come into contact with any treated skin area, including the breast.

Driving and operating machinery

The use of this medication does not affect your ability to drive and operate machinery.

Important information about some of the components of Lamisilcutaneous spray solution

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

Follow exactly the administration instructions of this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

How long to use Lamisil

Apply the topical solution to the affected area one or two times a day, as indicated below, unless your doctor tells you otherwise.

• Tinea pedis(athlete's foot): once a day for one week.
• Tinea crurisandTinea corporis: once a day for one week.
• Pitiriasis versicolor: two times a day for one week.

Usage instructions

Follow these instructions carefully:

• Clean and dry the affected skin areas and surrounding areas, and wash your hands.
• Remove the cap and gently press the bottle.
• Apply enough solution to completely moisten the affected skin area and surrounding area.
• Replace the cap on the bottle.
• Wash your hands after using the solution, as it could spread the infection to other areas of your own skin or to others.

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

Dispose of any remaining solutionafter 12 weeks from the first opening.

To help with treatment

Keep the affected skin area clean by washing it regularly. Gently pat it dry without rubbing. Try not to scratch the area, even if you feel itchy, as it could 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 do not share them with anyone. To protect yourself from re-infection, wash your clothes and towels frequently.

If you use moreLamisilthan 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, contact the Toxicological Information Service. Phone 91 562 04 20.

If you forget to use Lamisil

If you forget to apply the topical 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 usual amount and continue with the usual schedule.

Do not apply a double dose to compensate for the missed doses.

Use the topical solution as indicated. This is important, as the infection could reappear if you forget several applications.

If you interrupt treatment with 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 reappear if you interrupt treatment too early.

If you have any other doubts about using this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

STOP using Lamisil and seek immediate medical help if 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 pimples

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

Skin peeling, itching.

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

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

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

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

Ocular irritation.

Worsening of skin condition.

Other reported adverse effects(frequency unknown)

Allergic reaction (hypersensitivity)

Rash

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

Reporting Adverse Effects

If you experienceany type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is apossibleadverse effect not listed in this prospectus.You can alsoreport them directlythrough the Spanish System for Pharmacovigilance of Medicinal Products for Human Use (www.notificaRAM.es). Byreporting adverse effects, you can contribute to providing more information on the safety of this medication.

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.

Do not store at a temperature above 30°C. Do not refrigerate.

Replace the cap on the bottle after use. Dispose of any remaining solution 12 weeks after its first opening.

Medications should not be thrown down the drains or in the trash.Deposit the containers and medications you no longer need at theSIGREcollection pointat the pharmacy. If in doubtask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Lamisil 10 mg/g topical solution for powdering

• The active ingredient is terbinafine hydrochloride. One gram of Lamisil topical solution contains 10 mg of terbinafine hydrochloride, equivalent to 8.8 mg of terbinafine base.
• The other components are: purified water, ethanol (23.5% p/p), propylene glycol (E-1520), and cetostearyl macrogol ether.

Appearance of the product and contents of the packaging

Lamisil topical solution is a transparent, colorless to slightly yellowish liquid. It is presented in 30 ml bottles.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 – Barcelona

Spain

Responsible for Manufacturing

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

Last review date of this leaflet:March 2022

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