RECTO

Proof A

<

42 mm

->j

14 mm

Pharma code 177

LL \ epoo eujjeL|_c

lulu 9/

►

Read all of this leaflet carefully because it contains

important information for you.

This medicine is available without prescription.

However, you still need to use Lamisil AT 1% Spray

carefully to get the best results from it.

-    Please keep this leaflet. You may need to read it again.

-    Ask your pharmacist if you need more information or advice.

-    You must contact a doctor if your symptoms worsen or do not improve after 7 days.

-    If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Lamisil AT 1% Spray is and what it is used for

2.    Before you use Lamisil AT 1% Spray

3.    How to use Lamisil AT 1% Spray

4.    Possible side effects

5.    How to store Lamisil AT 1% Spray

6.    Further information

1. What Lamisil AT 1% Spray is and what it is used for

Lamisil AT 1% Spray contains the active ingredient terbinafine which is an antifungal used to treat skin problems caused by fungi in:

•    Athlete's foot (tinea pedis) - Athlete's foot appears only on the feet (usually both, but not always), where it often appears in between the toes. It can also appear on the instep, soles, or other areas of the feet. The most common type of athlete's foot causes cracking or scaling of the skin, but you may also have mild swelling, blisters, or weeping ulcers. Lamisil AT 1 % Spray

is recommended for athlete's foot when it occurs between the toes. If you have a fungal nail infection (fungus inside and under the nail) with discolouration of the nails and changes in nail texture (thick or flaky), you should consult your doctor because Lamisil AT 1% Spray is not appropriate for this type of infection.

•    Dhobie itch/jock itch (tinea cruris) - Dhobie itch appears in the groin and inner thigh area, usually on both sides but often with one side more than the other, where it can spread further between the legs to the buttocks, or up towards the stomach. Dhobie itch looks like a clearly bordered rash, which may have blisters.

2. Before you use Lamisil AT 1% Spray

DO NOT use Lamisil AT 1% Spray if you have:

•    an allergy (hypersensitivity) to any of the ingredients in the product (see Section 6 and end of Section 2). The spray is NOT recommended for children under 16 years of age.

Take special care with Lamisil AT 1% Spray

The spray is for application on the skin only.

•    Avoid inhaling the product.

•    Eyes, mouth or face - avoid contact of the spray.

In case of accidental contact with eyes, rinse thoroughly with running water.

•    Damaged skin - avoid application to where alcohol (one of the ingredients) could cause stinging or irritation.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription. Do not apply other medicines on the areas you are treating with Lamisil AT 1% Spray.

Pregnancy and breast-feeding

If you are pregnant ask your doctor before using this medicine. Do not use the spray if you are breastfeeding.

Driving and using machines

Lamisil AT 1% Spray is not expected to affect your ability to drive or operate machinery.

Important information about some of the ingredients of Lamisil AT 1% Spray Propylene glycol - may cause skin reactions. Alcohol - contains 20.5% w/w

3. How to use Lamisil AT 1% Spray

Always use this medicine exactly as described in this

leaflet or as advised by your doctor or pharmacist.

Adults

Lamisil AT 1% Spray is applied once a day, for one

week only, for all fungal infections.

•    Cleanse and dry the affected areas thoroughly and wash your hands. Treatment can be helped by keeping the affected areas clean by regular washing and careful drying with your own

clean towels and clothes, and not rubbing S or scratching the skin.    §

•    Remove the cap from the spray bottle - If using J the medicine for the first time, press the pump | a few times until you achieve an even spray. |

<r

54 mm

►

³harma code 177

Proof A

5. How to store Lamisil AT 1% Spray

•    Spray enough of the solution from a distance of 5 to 10 cm to thoroughly wet the affected skin. When used between the toes, buttocks or on the groin, the treated area may be covered with a light, fresh gauze strip, especially at night.

•    Replace the cap on the spray bottle and wash your hands.

Even though you will not be using Lamisil AT 1% Spray during the second week, full skin healing after the infection has cleared will continue for up to 4 weeks. If you have not noticed any signs of improvement within 2 weeks of first starting treatment, please seek advice from your doctor or pharmacist.

Children under 16 years

NOT recommended.

Avoid inhaling the spray.

If the product accidentally gets into your eyes, rinse thoroughly with running water. Consult your doctor if any discomfort persists.

If you accidently swallow Lamisil AT 1% Spray

Contact your doctor or nearest hospital emergency department if you, or someone else, has swallowed some spray. Take any remaining medicine and this leaflet with you if possible. Symptoms of accidental ingestion include headache, nausea (feeling sick), dizziness and stomach pain.

If you forget to use Lamisil AT 1% Spray

If you miss an application, apply the spray as soon as possible then carry on as before. If you only remember at the time of your next application, just apply the spray and carry on as normal. It is important to try to use the spray at the correct times as forgotten applications could risk the infection returning.

If you stop using Lamisil AT 1% Spray

You should not stop using the spray before the recommended time as this may reduce the effectiveness of treatment or the infection may return. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, Lamisil AT 1% Spray can cause side effects, although not everybody gets them.

STOP using the spray and seek medical help immediately if you have any of the following very rare allergic reactions:

•    Difficulty breathing or swallowing, swelling of the mouth, face, lips, tongue or throat (severe allergic reaction).

•    Severe itching of the skin, with red rash or raised lumps, hives or blisters

Common: (may affect up to 1 in 10 people): skin peeling, itching.

Uncommon: (may affect up to 1 in 100 people): skin lesions, scab, skin colour changes, redness, burning, pain and irritation at the site of application.

These common and uncommon side effects are usually harmless and you can carry on using the spray.

Rare: (may affect up to 1 in 1000 people): eye irritation, dry skin, contact dermatitis, eczema, worsening of symptoms.

If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.

Do not store Lamisil AT 1% Spray above 30°C (do not refrigerate). Keep the bottle closed and in its carton. Do not use or keep this medicine after the expiry (EXP) date shown on the box and container. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Further information

What Lamisil AT 1% Spray contains The active ingredient is terbinafine, 1% w/v.

The other ingredients are water, ethanol, propylene glycol and cetomacrogol 1000 (see also Section 2 ‘Important information about some of the ingredients of Lamisil AT 1% Spray').

What Lamisil AT 1% Spray looks like and contents of the pack

The spray is available in white, round, 15 ml plastic bottles with a spray pump.

Marketing Authorisation Holder and Manufacturer

Novartis Consumer Health UK Limited

Watchmoor Park

Camberley

Surrey

GU15 3YL, UK

® Lamisil AT 1% Spray is a registered trade mark This leaflet was last revised in March 2014.

GB 924341 - 5028359 GB    (!) NOVARTIS

Pharma code 177

<r

►