LAMISIL

LAMISIL Cream

Important notes (mandatory information)

Lamisil Cream 1%. Active ingredient: Terbinafine hydrochloride. Areas of application: Fungal infections of the skin, such as athlete's foot (tinea pedis; including the treatment of an exposed nail bed, e.g. as a result of nail-dissolving nail fungus therapy), fungal skin infections on the thighs and body (tinea corporis), fungal skin infections in the groin area (tinea cruris), cutaneous candidiasis, pityriasis versicolor, caused by dermatophytes, yeasts or other fungi (Pityrosporum orbiculare/Malassezia furfur).

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Lamisil Cream 1 %
Active ingredient: Terbinafine hydrochloride

Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
• If you do not feel better or if you feel worse, talk to your doctor.

This leaflet contains

1. WHAT IS LAMISIL CREAM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU KNOW BEFORE USING LAMISIL CREAM?
3. HOW TO USE LAMISIL CREAM?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE LAMISIL CREAM?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS LAMISIL CREAM AND WHAT IS IT USED FOR?

Lamisil Cream is a broad-spectrum antifungal agent for the treatment of fungal infections (mycoses) of the skin. Terbinafine hydrochloride, the active ingredient in Lamisil Cream, penetrates the affected skin layers, inhibits the growth of the fungus there and kills it. Areas of application: Fungal infections of the skin, such as athlete's foot (tinea pedis; including the treatment of an exposed nail bed, e.g. as a result of nail-dissolving nail fungus therapy), fungal skin infections on the thighs and body (tinea corporis), fungal skin infections in the groin area (tinea cruris), cutaneous candidiasis, pityriasis versicolor, caused by dermatophytes, yeasts or other fungi (Pityrosporum orbiculare/Malassezia furfur). Lamisil Cream has a long-term effect. If the dosage recommendation is followed, less than 10 out of 100 patients with athlete's foot will experience a new infection within three months of starting therapy.

2. WHAT SHOULD YOU KNOW BEFORE USING LAMISIL CREAM?

Lamisil Cream must not be used if you are hypersensitive (allergic) to terbinafine or any of the other ingredients of this medicine (listed in section 6 and at the end of section 2).

Warnings and precautions

Please talk to your doctor or pharmacist before using Lamisil Cream. For external use only. Do not use in the mouth or swallow. Be careful not to get the cream in your eyes. If the cream accidentally gets in your eye, wipe it off and rinse your eye thoroughly with running water. If the discomfort persists, please see a doctor.

Children and adolescents

As there is insufficient experience, children under 5 years of age should not be treated with Lamisil Cream.

Use of Lamisil Cream with other medicines

Tell your doctor or pharmacist if you are taking/using or have recently taken/used or intend to take/use any other medicines. Do not apply other medicines to the area to be treated. In the case of treatment in the genital or anal area, the excipients ("stearate") contained may reduce the tear resistance of latex condoms and thus impair the safety of these products. Interactions between Lamisil Cream and other agents are not known to date.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine. You should not use this medicine during pregnancy unless it is absolutely necessary. Do not use Lamisil Cream while you are breast-feeding. Infants and toddlers must not come into contact with the treated skin areas, including the breasts.

Driving and using machines

Lamisil Cream does not affect the ability to drive and use machines.

Important information about certain other ingredients of Lamisil Cream

Lamisil Cream contains stearyl alcohol and cetyl alcohol, which can cause local skin reactions (e.g. contact dermatitis).

3. HOW TO USE LAMISIL CREAM?

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Please ask your doctor or pharmacist if you are not sure. It is important that you use Lamisil Cream correctly. Follow the instructions exactly. If you suffer from a nail fungus infection (upper or lower surface of the nail) with discoloration of the nails and/or a change in the nail structure (brittle, thickened), you should consult your doctor. Lamisil Cream is not suitable for this type of infection.

Instructions for use:

• Before use, you should clean the affected skin areas and your hands thoroughly and dry them well.
• Unscrew the tube. If it is still sealed, you can pierce the foil with the spike in the cap.
• Put a small amount of cream on your finger and close the tube again.
• Apply the cream in a thin layer to the affected skin area and the surrounding skin and rub it in gently.
• After touching the infected skin area, please wash your hands so that the infection cannot spread further.

If you are treating fungal infections in skin folds of the body (e.g. under the breasts, between the fingers or toes, in the anal fold, between the thighs), you can cover these skin areas, especially overnight, with a gauze pad. Please use a new clean gauze pad each time. Before applying Lamisil Cream to large skin areas (more than 10% of the body surface, corresponding to approx. 10 palms), please consult your doctor.

How often and for how long should you use Lamisil Cream?
Unless otherwise prescribed by your doctor, Lamisil Cream is applied once a day to the affected skin areas and rubbed in.

Disease	How often to use?	How long to use?
Athlete's foot between the toes (Tinea pedis interdigitalis)	1 x daily	1 week
Athlete's foot on the sole of the foot (Tinea pedis plantaris)	1 x daily	4 weeks
Fungal skin infections on the body (ringworm = Tinea corporis), fungal skin infections in the groin area (Indian washerman's itch = Tinea cruris)	1 x daily	1 — 2 weeks
Yeast fungal infection of the skin (cutaneous candidiasis)	1 x daily	2 weeks
Pityriasis versicolor	1 x daily	2 weeks

Yeast fungal infections (cutaneous candidiasis) may sometimes manifest themselves as ringworm or washerman's itch, but occur in older or overweight patients in whom a moist environment develops in skin folds or in patients with other conditions such as diabetes. Treatment of candidiasis may require a longer duration of treatment (2 weeks). Continue treatment for the recommended duration of use, even if the symptoms have subsided after a few days. Symptoms usually improve after a few days, but they may recur if the cream is not used regularly or if treatment is stopped prematurely. With Lamisil Cream, your skin condition should improve within a few days. However, it may take up to four weeks for the damaged skin to heal completely after the condition has subsided. Lamisil Cream continues to work after you have stopped treatment, so your skin should continue to improve. If you do not notice any signs of improvement within two weeks of starting treatment, please contact your doctor or pharmacist for advice.

Supporting the treatment

To support the treatment, please pay attention to good hygiene by cleaning the affected skin area regularly. Dry yourself thoroughly without rubbing, by gently patting the area dry. Despite itching, try not to scratch, as this can lead to further skin damage and delayed healing or spread of the infection. Change towels, clothing and stockings that come into contact with the affected skin area regularly and wash them at at least 60°C. If this is not possible, you should at least use a hygiene rinse. Prefer natural materials, such as cotton. This will help prevent transmission to other parts of the body and to other people.

Elderly people

There is no evidence that a different dosage is required for elderly people.

If you have used more Lamisil Cream than you should

Cases of overdose of Lamisil Cream have not been reported with external use. However, if Lamisil Cream is accidentally ingested, side effects such as those that can occur with an overdose of Lamisil tablets (e.g. headache, nausea, pain in the upper abdomen and dizziness) can be expected. In this case, contact your doctor or pharmacist immediately.

If you forget to use Lamisil Cream

If you forget to use Lamisil Cream, apply it as soon as possible. Then continue treatment as usual. If you do not remember until the next application, please apply the usual amount and then continue treatment as usual. Do not use double the amount if you have forgotten the previous application. Please use the cream according to the instructions for use. This is important because there is a risk of re-infection if several applications are forgotten.

If you stop using Lamisil Cream

The symptoms of the condition usually subside within a few days. Irregular use or premature discontinuation of treatment carries the risk of re-infection.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, Lamisil Cream can have side effects, although not everybody gets them.

The following frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Stop using Lamisil Cream and seek medical help immediately if you notice any of the following signs. It could be an allergic reaction:

• Difficulty breathing or swallowing.
• Swelling of the face, lips, tongue or throat.
• Severe itching of the skin with rash or papules (also beyond the application site).

The following side effects have also been reported

Common	Skin flaking, itching.
Uncommon	Skin damage, scabs, skin changes, skin discoloration, redness, burning, pain or irritation at the application site.
Rare	Dry skin, eczema, contact dermatitis, worsening of the underlying condition.
Not known	Hypersensitivity, rash.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE LAMISIL CREAM?

Keep out of reach of children. Do not use this medicine after the expiry date which is stated on the carton and the tube. The expiry date refers to the last day of the month. Keep the tube closed in the outer carton. Note on shelf life after opening: Lamisil Cream can be stored for 4 weeks after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

The active ingredient is terbinafine hydrochloride. 1 g of cream contains 10 mg of terbinafine hydrochloride. The other ingredients are: Purified water; Isopropyl myristate; Polysorbate 60; Cetyl alcohol; Stearyl alcohol; Cetyl palmitate; Sorbitan stearate; Benzyl alcohol; Sodium hydroxide.

What Lamisil Cream looks like and contents of the pack

Lamisil Cream is a white, shiny cream for application to the skin. Lamisil Cream is available in packs of 15 g cream and 30 g cream.

Pharmaceutical entrepreneur and manufacturer

GlaxoSmithKline Consumer Healthcare GmbH & Co. KG
80258 Munich
Barthstraße 4
80339 Munich
Telephone (089) 78 77-209
Telefax (089) 78 77-304
E-mail: medical.contactcenter@gsk.com

This leaflet was last revised in June 2016.

Source: Information from the package leaflet
Status: 12/2017
Active ingredient: Terbinafine hydrochloride. Areas of application: Fungal infections of the skin, such as athlete's foot (tinea pedis; including the treatment of an exposed nail bed, e.g. as a result of nail-dissolving nail fungus therapy), fungal skin infections on the thighs and body (tinea corporis), fungal skin infections in the groin area (tinea cruris), cutaneous candidiasis, pityriasis versicolor, caused by dermatophytes, yeasts or other fungi (Pityrosporum orbiculare/Malassezia furfur).