Lamisil 1% cream, 15 G

Lamisil 1% cream is an over-the-counter medicine containing the active ingredient terbinafine hydrochloride for the treatment of fungal infections of the skin. It works by killing the fungus that causes skin problems.

3-fold effective against athlete's foot and skin fungus

• Rapid relief
• Fights the symptoms
• Kills the fungus (fungicidal)

Lamisil 1% cream is used for adults and adolescents (aged 12 and over).

Lamisil 1% cream isavailable without prescription for self-treatment of the following skin infections(but you must use it carefully to get the best results) :

• Fungal infection of the feet (tinea pedis)*
• Fungal infection on the thighs and body (ringworm = tinea corporis)*
• Fungal infection on the lower legs (tinea cruris)*
• Fungal infections of the skin, mainly caused by the genus Candida (= skin candidiasis)*
• Pityriasis of the skin (Pityriasis versicolor)*

* See "How do you recognise that you have one of the above diseases?"

Lamisil 1% cream has a long-lasting effect. When used according to therecommended dosage, fewer than 10 people in 100 will suffer a new athlete's foot infection within 3 months of starting treatment .

How can you recognise that you have one of the above conditions?

• Tinea pedis (athlete's foot)

Tinea pedis (athlete's foot) only occurs on the feet (usually both, but not always), oftenbetween the toes. The fungus can also occur on the instep, on the soles, or in other areas of the feet. The most common type of athlete's foot causes cracking or scaling of the skin, but there may also be slight swelling, blisters or weeping ulcers. Lamisil 1% cream is recommended for athlete's foot that occurs between the toes.

If you have a nail fungus infection (fungus in and under the nail) with discolouration of the nails andchanges in the nail structure (thick, scaly), you should consult your doctor, as Lamisil 1% cream is not suitable for this type of infection. Prescription tablets containing terbinafine should be taken to treat nail fungus.

• Tinea corporis (ringworm)

Tinea corporis (ringworm) can occur anywhere on the body, often in wrinkled areas of the body,especially when the skin is moist. The groin area and the inner thigh area (usuallyboth sides, but often one side more severely)are frequentlyaffected. The fungus can spread between the legs, to thebuttocks or to the abdomen. It can also appear in the crease under the breasts, inthe armpits or in other wrinkled areas. The rash has a clear border and mayhave blisters that itch. If the fungal infection occurs on the head, neck, face and arms,ringwormcausescircular patches of red rash, but scalypatches and itching may alsooccur.

• Tinea cruris (fungal infection of the lower legs)

Tinea cruris (fungal infection of the lower legs) occurs mainly on the outside of the lower legsand causes red, pea-sized nodules with scaly edges, which are oftenassociated with severe itching.

• Skin candidiasis

Skin candidiasis (intertrigo or sweat rash) occurs in wrinkled, sweaty areas ofthe skin, e.g. under the breasts or in the armpits. Candidiasis usually occurs inolder or overweight patients or those with other conditions such as diabetes.It causes redness, itching and scaling.

• Pityriasis versicolor (clover lichen)

Pityriasis versicolor appears on the skin as scaly patches thatform white areas due toloss of pigment in the skin. The patches are most prominent in summer when the surroundingskin is normally tanned. The lichen generally appears on the trunk(below the neck to the waist), neck and arms, and may reappear within months, especially in hot weather and due to perspiration.

Dosage form

cream

How to use

For use on the skin only.

• Athlete's foot between the toes: 1 x daily for 1 week
• Tinea corporis and cruris: 1 x daily for 1 week
• Cutaneous candidamycosis: 1-2 x daily for 1-2 weeks
• Canker sores: 2 x daily for 1 week

Adults and adolescents (from 12 years):

• Before first use, the sealing membrane of the tube must be pierced with the spike in thescrew cap.
• Wash and dry the affected areas of skin and the surrounding areas andwash your hands.
• Open the tube and apply a small amount of cream to your finger.
• Put the cap back on the tube.
• Apply a thin layer of cream to the affected areas of skin and the surroundingareas .
• Gently rub the cream into the skin.
• Wash your hands after applying the cream, otherwise the infection may spread toother areas of the skin or to other people.

If you are treating an infection in the skin folds, you cancover the affected area with agauze strip, especially at night. If you do this, use a fresh, clean gauze strip each time you apply the cream.

Duration and frequency of treatment

Apply Lamisil 1% cream to the infected areas as follows:

• Fungal infection of the feet (tinea pedis): apply once a day for 1 week.
• Fungal infection of the thighs and body (ringworm = tinea corporis):Apply oncea day for 1 week.
• Fungal infection on the lower legs (tinea cruris): Apply once a day for 1 week.
• Fungal infections caused by yeast fungi (Candida, skin candidiasis):Apply once ortwice a day for 1-2 weeks.

This fungal infection may look like ringworm or a fungal infection of the groin, but it occursin older or overweight patients with moist areas in the overlapping skin folds, or in those with other conditions such as diabetes. The longer course of treatment (2 weeks) may be required to treat candidiasis.

• Candidiasis of the skin (pityriasis versicolor): Apply twice daily for 1 week.

Use the cream for the recommended treatment period, even if the infectionimproves aftera few days. Infections usually improve within a few days, but may recur if the cream is not applied regularly or treatment is stopped too soon.

Lamisil 1% cream should improve the condition of your skin in a few days. However,once the infection has healed, the skin will takelonger to heal completely, possibly up to4 weeks. Lamisil 1% cream continues to work even after you have finished treatment.

Ingredients

• The active ingredient is: terbinafine hydrochloride.
• 1 g cream contains 10 mg terbinafine hydrochloride, corresponding to 8.8 mg terbinafine.
• The other ingredients are: Sodium hydroxide, benzyl alcohol (as a preservative),sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate,purified water.