Label: information for the user

Lamisil 10 mg/g cream

Terbinafine hydrochloride

Read the entire label carefully before starting to use the medication, as it contains important information for you.

• Conserve this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may 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 section 4.

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

Lamisil cream is used for the treatment of:

• 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 fungi, known as candidiasis
• Skin infection caused by yeast, known as pityriasis versicolor.

Do not use Lamisil cream:

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

Inform your doctor or pharmacistif this is the case anddo not useLamisil cream.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Lamisil cream

• Children under 12 years of ageshould not use Lamisil cream.
• Lamisil cream is for external use only. Do not use it in the mouth or swallow it.
• Avoid contact with 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.

Use of Lamisil cream with other medications

• Do not apply other medications or treatments to the affected area(includingthose purchased without a prescription) at the same time as Lamisil cream.
• Inform your doctor or pharmacistif you are using, have used recentlyor may need to use anyother medication, including those purchased without a prescription.

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 this medication. Lamisil cream should not be used during pregnancy unless strictly necessary.
• Do not use Lamisil cream while breastfeeding. Avoid contact between the treated skin area and the baby, including the breast.

No special recommendations are made for women of childbearing age.

Driving and operating machinery

The use of Lamisil cream does not affect your ability to drive and operate machinery.

Important information about one of the components of Lamisil cream

This medication contains 10 mg of benzyl alcohol per gram of cream.

Benzyl alcohol may cause allergic reactions and moderate local irritation.

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

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

Apply the cream 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.
• Skin candidiasis: one or two times a day for one week.
• Pityriasis versicolor: one or two times a day for two weeks.

Usage Instructions

Follow these instructions carefully:

• Clean and dry the affected skin areas and surrounding areas, and wash your hands.
• Remove the cap and, if using for the first time, use the incorporated point to pierce the top of the tube.
• Gently squeeze the tube to apply a thin layer of cream to the affected skin and surrounding area.
• Gently rub the cream into the skin.
• Replace the cap on the tube.
• Wash your hands after applying the cream, as it may spread the infection to other areas of your own skin or to others.

If the infection is located between the folds of the skin (e.g. between the fingers or toes, under the breasts or in the groin, in the buttocks or underarms), it is recommended to cover the treated area with a gauze dressing, especially at night. In this case, use a clean piece of gauze each time the cream is applied.

You will start to notice improvement a few days after starting treatment with Lamisil cream, but you will need more time to achieve complete healing. The effects of Lamisil cream will continue even after the treatment period has ended.

If, after two weeks of treatment, there are no signs of improvement,consult your doctor or pharmacist.

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 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 do not share them with anyone. To protect yourself from re-infection, wash your clothes and towels frequently.

If you use more Lamisil cream 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 Toxicological Information Service. Phone 91 562 04 20.

If you forget to use Lamisil cream

If you forget to apply the cream, 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 make up for the missed doses.

If you interrupt treatment with Lamisil cream

Apply Lamisil cream until the recommended treatment period is completed, even if the infection seems to improve after a few days. The infection may reappear if treatment is stopped too early.

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

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

STOP using Lamisil cream and seek medical help immediately 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 infrequent(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 with itching and rash, skin redness and burning (eczema).

Eye irritation.Worsening of skin condition.

Other reported adverse effects(frequency unknown)

Allergic reaction (hypersensitivity)

Rash

Reporting 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 prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use, https://www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication

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

Do not store at a temperature above 30°C.

Keep the tube perfectly closed and in the outer packaging.

Do not use the cream after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and medicines you no longer need at the SIGRE of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. By doing so, you will help protect the environment.

Composition of Lamisil 10 mg/g cream

• The active ingredient is terbinafine hydrochloride. One gram of Lamisil cream contains 10 mg of terbinafine hydrochloride, equivalent to 8.8 mg of terbinafine base.
• The other components are: sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearic alcohol, polisorbate 60, isopropyl myristate, purified water.

Appearance of the product and contents of the packaging

Lamisil cream is a bright, uniform, and white cream. It is presented in 30 g tubes.

Holder of the marketing authorization

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

Last review date of this leaflet: June 2018

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