LAMISIL 10 mg/g CREAM

2. What you need to know before starting to use Lamisil cream

Do not use Lamisil cream:

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

Tell your doctor or pharmacist if this is the case and do not use Lamisil 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.
• For external use only. Do not use in the mouth or swallow.
• Avoid contact with the eyes, as it may be irritating to them. If the medicine accidentally comes into contact with your eyes, rinse them thoroughly with plenty of water and consult your doctor if any discomfort persists.

Using Lamisil cream with other medicines

• Do not apply other medicines or treatments to the affected area(including those purchased without a prescription) at the same time as Lamisil cream.
• Tell your doctor or pharmacistif you are using, have recently used, or may need to use any other medicine, 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 medicine. Lamisil cream should not be used during pregnancy unless strictly necessary.
• Do not use Lamisil cream while breastfeeding. You should avoid letting nursing babies come into contact with any treated skin area, including the breast.

There are no special recommendations for women of childbearing age.

Driving and using machines

Using Lamisil cream does not affect your ability to drive or use machines.

Important information about some of the ingredients of Lamisil cream

This medicine contains 10 mg of benzyl alcohol in each gram of cream.

Benzyl alcohol may cause allergic reactions and moderate local irritation.

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

3. How to use Lamisil cream

Follow the instructions for administration of this medicine indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

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

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, if using for the first time, use the incorporated tip 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.
• Rub the cream gently into the skin.
• Replace the cap on the tube.
• Wash your hands after applying the cream; otherwise, you may spread the infection to other areas of your skin or to others.

If the infection is between skin folds (e.g., between fingers or toes, under the breasts, or in the groin, buttocks, or armpits), 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 you apply the cream.

A few days after starting treatment with Lamisil cream, you will start to notice improvement; however, 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 the treatment

Keep the affected skin area clean, washing it regularly. Dry it carefully with gentle strokes 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 do not share them with anyone. To protect yourself from reinfection, 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 Toxicology 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 normal amount and continue with the usual routine.

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

If you interrupt treatment with Lamisil cream

Apply Lamisil cream until you complete the recommended treatment period, even if the infection seems to improve after a few days. The infection may recur if treatment is interrupted too early.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

STOPusing Lamisil cream and seek immediate medical attention 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 side effects are common(may affect up to 1 in 10 patients)

Exfoliation of the skin, 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)

Dryness of the skin, 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

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for human use medicines, https://www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Lamisil cream

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

Do not store above 30°C.

Keep the tube tightly closed and in the outer packaging.

Do not use the cream after the expiry date stated on the packaging after EXP. The expiry date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the pharmacy's SIGRE. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package contents and additional information

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 ingredients are: sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.

Appearance of the product and package contents

Lamisil cream is a shiny, uniform, and white cream. It is available in 30 g tubes.

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

Date of the last revision of this leaflet: June 2018

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