LAMISIL Spray

Important notes (mandatory information)

Lamisil Spray 1%. Active ingredient: Terbinafine hydrochloride. Areas of application: Fungal infections of the skin caused by dermatophytes, pityriasis versicolor of the skin (pityriasis versicolor) in adults. Warning: contains propylene glycol. Read the package leaflet!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Lamisil Spray 1%, 1% spray for application to the skin, solution
Active ingredient: Terbinafine hydrochloride

Read the entire package leaflet carefully before you start using this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse after 2 weeks, contact your doctor.

What this package leaflet contains

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

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

Lamisil Spray is a medicine for the treatment of fungal infections of the skin (antimycotic). It works by killing the fungus that causes skin problems.

Area of application:

• Fungal infection of the feet (Tinea pedis interdigitalis)
• Fungal infection in the groin area (Tinea cruris)
• Fungal infection of the body (ringworm = Tinea corporis)
• Pityriasis versicolor of the skin (Pityriasis versicolor)

If you are not sure what is causing your infection, please talk to your doctor or pharmacist before using Lamisil Spray.

2. WHAT SHOULD YOU CONSIDER BEFORE USING LAMISIL SPRAY?

Lamisil Spray must not be used,

• if you are allergic to terbinafine or any of the other ingredients of this medicine listed in section 6 and at the end of section 2.

Please inform your doctor or pharmacist if this applies to you and do not use Lamisil Spray.

Warnings and precautions

Please talk to your doctor or pharmacist before using Lamisil Spray.

• Lamisil Spray is for external use only. It must not be used in the mouth or swallowed.
• Avoid contact of the spray with the face, eyes or on damaged skin, as alcohol can be irritating there. If the solution (spray) accidentally gets into your eyes, you should rinse your eyes thoroughly with running water. If you experience persistent discomfort, please contact your doctor.
• Do not inhale the spray.
• Lamisil Spray contains alcohol. Keep it away from open fire.

Children and adolescents

Children and adolescents under 18 years of age should not use Lamisil Spray.

Use of Lamisil Spray with other medicines

Tell your doctor or pharmacist if you are taking / using, have recently taken / used or intend to take / use any other medicines. Do not use any other medicines or treatments on the affected area during treatment with Lamisil Spray, even if they are not prescription medicines.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Lamisil Spray should only be used during pregnancy after consulting a doctor. Lamisil Spray must not be used during breastfeeding. Infants must not come into contact with treated skin, including the breast.

Driving and using machines

The use of Lamisil Spray has no influence on the ability to drive and use machines.

Lamisil Spray contains propylene glycol

Lamisil Spray contains propylene glycol, which can cause skin irritation.

3. HOW TO USE LAMISIL SPRAY?

Always use this medicine exactly as described in the package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. It is recommended to apply the spray once or twice a day for one week as described below.

Instructions for use

Adults:

• Clean and dry the affected skin areas and surrounding areas and wash your hands.
• Remove the cap from the spray bottle.
• Before using for the first time, the spray head must be pressed several times until an even spray is emitted.
• A sufficient amount of the solution should be sprayed so that the affected skin areas and the surrounding area are thoroughly wetted. The bottle can be held upright or upside down to make it easier to reach the affected skin areas.
• Replace the cap on the bottle.
• Wash your hands after applying the spray, otherwise the infection may spread to other areas of the skin or to other people.

Frequency and duration of use of Lamisil Spray

Unless otherwise prescribed by your doctor, apply the spray once or twice a day to the affected areas as follows:

• Fungal infection of the feet (Tinea pedis interdigitalis): once a day for 1 week
• Fungal infection of the body (Tinea corporis, Tinea cruris): once a day for 1 week
• Pityriasis versicolor (Pityriasis versicolor): twice a day for 1 week

Your skin should improve within a few days, but it may take up to 4 weeks to heal completely. If you do not notice any signs of improvement within 2 weeks of using Lamisil Spray, please consult your doctor or pharmacist for advice. The remaining spray must be disposed of 12 weeks after first opening.

What measures can support the treatment?
Keep the affected areas clean and wash them regularly. Dry them carefully without rubbing or dab them gently. Even if the skin areas itch, try not to scratch, as this can worsen the symptoms and slow down the healing process or the infection can spread further. Use your own towels and clothing and do not share them with other people, as these infections are easily transmitted. Wash your clothes and towels frequently to protect yourself from re-infection.

If you forget to use Lamisil Spray

If you forget to use the spray, apply it as soon as possible and continue treatment as usual. If you only notice it when it is time for the next application, simply apply the usual amount and then continue as normal. Do not use double the amount to make up for a missed application. Use the spray as directed, as missed applications may increase the risk of re-infection.

What should you do if Lamisil Spray is accidentally swallowed?
Consult your doctor immediately. He will tell you what to do. The alcohol content must be taken into account.

What should you do if the product accidentally gets into your eyes?
Rinse your eyes thoroughly with running water. If you experience persistent discomfort, please contact your doctor. 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, this medicine can cause side effects, although not everybody gets them.

The following categories are used to classify the frequency of 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.

Some people are allergic to Lamisil Spray, which can cause swelling and pain, rash or hives. The frequency of an allergic reaction is not known (cannot be estimated from the available data). If you notice these symptoms, stop using the solution and inform your doctor or pharmacist immediately.

Common	Skin peeling and itching at the site of application
Uncommon	Skin injury, scab, skin changes, changes in pigmentation, redness, burning, pain and irritation at the site of application
Rare	Skin dryness, eczema, worsening of the condition. If Lamisil Spray accidentally gets into the eyes, eye irritation may occur.
Not known	Skin rash

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Department 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 SPRAY?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and the bottle label after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 30 °C. Do not refrigerate or freeze. Replace the cap on the bottle after use. Discard any remaining spray 12 weeks after first opening. Do not dispose of medicines in wastewater or household waste. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Lamisil Spray contains;
The active ingredient is terbinafine hydrochloride.
1 g solution contains 10 mg terbinafine hydrochloride (1% w/w).

The other ingredients are

Purified water; Ethanol 96 %; Propylene glycol (E1520); Macrogol cetostearyl ether.

What Lamisil Spray looks like and contents of the pack

Lamisil Spray is a clear, colourless to slightly yellow liquid for application to the skin. Lamisil Spray is available in packs of 15 ml solution and 30 ml solution with spray pump. Not all pack sizes may be marketed.

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@ask.com

This leaflet was last revised in June 2016.

Source: Information from the package leaflet
Status: 01/2018
Active ingredient: Terbinafine hydrochloride. Areas of application: Fungal infections of the skin caused by dermatophytes, pityriasis versicolor of the skin (pityriasis versicolor) in adults. Warning: contains propylene glycol. Read the package leaflet!