Lamisil 10 mg/g cream

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Lamisil 10 mg/g cream

Terbinafine hydrochloride

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

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

Leaflet contents

1. What Lamisil cream is and what it is used for
2. What you need to know before using Lamisil cream
3. How to use Lamisil cream
4. Possible adverse effects
5. How to store Lamisil cream
6. Contents of the pack and other information

1. What Lamisil cream is and what it is used for

Lamisil cream is an antifungal agent intended for use on the skin. It works by preventing the growth of fungi responsible for skin problems.

Lamisil cream is used to treat:

• Athlete's foot (Tinea pedis)
• Fungal skin infection affecting the groin area, known as Tinea cruris
• Fungal skin infection affecting any part of the body, known as Tinea corporis
• Fungal skin infection known as candidiasis
• Skin infection caused by yeasts known as pityriasis versicolor.

2. What you need to know before using Lamisil cream

Do not use Lamisil cream:

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

Inform your doctor or pharmacist if this applies to you and do not use Lamisil cream.

Warnings and precautions

Talk to your doctor or pharmacist before using Lamisil cream

• Children under 12 years of age must 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. If the medicine accidentally comes into contact with your eyes, rinse them thoroughly with plenty of water and consult your doctor if discomfort persists.

Using Lamisil cream with other medicines

• Do not apply other medicines or treatments to the affected area (including those obtained without a prescription) at the same time as Lamisil cream.
• Tell your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines, including those obtained without a prescription.

Pregnancy, breast-feeding and fertility

• If you are pregnant or breast-feeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine. Lamisil cream must not be used during pregnancy unless strictly necessary.
• Do not use Lamisil cream while breast-feeding. Breastfeeding infants must be prevented from coming into contact with any treated skin area, including the breast.

There are no special recommendations for women of childbearing age.

Driving and Use of Machines

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

Important Information about Some of the Components of Lamisil Cream

This medicinal product contains 0.01 g of benzyl alcohol in each gram of cream.

Benzyl alcohol may cause allergic reactions and moderate local irritation.

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

3. How to use Lamisil cream

Follow exactly the instructions for use of this medicine provided by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

Apply the cream to the affected area once or twice daily, as indicated below, unless your doctor has instructed otherwise.

• Tinea pedis (athlete's foot): once daily for one week.
• Tinea cruris and tinea corporis: once daily for one week.
• Cutaneous candidiasis: once or twice daily for one week.
• Pityriasis versicolor: once or twice daily for two weeks.

Instructions for use

Carefully follow the instructions below:

• Clean and dry the affected skin areas and surrounding regions, then wash your hands.
• Unscrew the cap, and if using for the first time, remove the seal from the top of the tube.
• Gently squeeze the tube to apply a thin layer of cream onto 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; otherwise, you could spread the infection to other areas of your own skin or to other people.

If the infection is located in skin folds (e.g., between fingers or toes, under the breasts, in the groin, buttocks, or armpits), it is advisable 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 should begin to notice improvement within a few days of starting treatment with Lamisil cream; however, it will take longer to achieve complete healing. The effects of Lamisil cream will continue even after the treatment period has ended.

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

To help the treatment

Keep the affected skin area clean by washing it regularly. Dry it carefully by gently dabbing—do not rub. Try not to scratch the area, even if it itches, as this could harm the skin, delay healing, or spread the infection.

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

If you use more Lamisil cream than you should

If you have accidentally swallowed any of the product, inform your doctor immediately. They will advise you on what to do.

In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 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, then continue with the next dose at the usual time. If you remember at the time of the next scheduled application, simply apply the normal amount and continue with the regular dosing schedule.

Do not apply a double dose to make up for a missed dose.

If you stop using Lamisil cream

Apply Lamisil cream for the full recommended treatment duration, even if the infection appears to improve after a few days. The infection may recur if treatment is stopped too early.

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 everyone experiences them.

DISCONTINUE use of Lamisil cream 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 exfoliation, itching.

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

Skin lesion, crusting, skin disorder, changes in skin color, skin redness (erythema), burning sensation, pain, pain at application site, irritation at application site.

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

Dry skin, rash and itching (contact dermatitis), redness and burning (eczema).
Eye irritation.
Worsening of skin condition.

Other reported adverse effects (frequency not known)

Allergic reaction (hypersensitivity)
Rash

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 via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Lamisil cream

Keep this medicine out of sight and reach of children.

Do not store above 30°C.

Keep the tube tightly closed and store it in the outer packaging.

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

Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Lamisil 10 mg/g cream

• The active substance 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, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water.

Appearance of the medicine and contents of the pack

Lamisil cream is a smooth, uniform, white, glossy cream. It is supplied in 30 g tubes.

Marketing Authorisation 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

Date of the most recent revision of this leaflet:

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/