Information for the user

Athlete’s Foot 1 % w/w Cream (Terbinafine Hydrochloride)

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 Athlete's Foot 1% w/w Cream 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.

•    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 Athlete's Foot 1 % w/w Cream is and what it is used for

2.    Before you use Athlete's Foot 1% w/w Cream

3.    How to use Athlete's Foot 1 % w/w Cream

4.    Possible side effects

5.    How to store Athlete's Foot 1 % w/w Cream

6.    Further Information.

1. What Athlete's Foot 1 % w/w Cream is and what it is used for

Athlete's Foot 1 % w/w Cream contains the active ingredient terbinafine hydrochloride which is an antifungal used to treat fungal skin infection such as:

•    Athlete’s foot (tinea pedis) - Athlete’s foot appears only on the feet (usually both, but not always), usually 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. Athlete's Foot 1% w/w Cream is recommended for athletes 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 Athlete's Foot 1 % w/w Cream 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 Athlete's Foot 1% w/w Cream

DO NOT use Athlete's Foot 1% w/w Cream if you:

are allergic (hypersensitive) to any of the ingredients in the product (see Section 6)

The cream is NOT recommended for use on children under 16 years of age.

Take special care with Athlete's Foot 1% w/w Cream

The cream is for external use only. Do not use on the face. Avoid contact with the eyes. In case of accidental contact with eyes, rinse thoroughly with running water.

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.

Pregnancy and breast-feeding

Do not use the cream if you are pregnant or breastfeeding, unless advised to by your doctor.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

Athlete's Foot 1 % w/w Cream is not expected to affect your ablility to drive or operate machinery.

Important information about some of the ingredients of Athlete's Foot 1 % w/w Cream

•    cetyl alcohol and stearyl alcohol: May cause local skin reactions (e.g. contact dermatitis).

3. How to use Athlete's Foot 1% w/w Cream

Always use this medicine exactly as described in this leaflet or as advised by your doctor or pharmacist.

Adults

For Athlete's Foot and dhobie itch, apply the cream once a day for one week.

•    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 or scratching the skin.

•    Unscrew the cap then gently squeeze out a small amount of the cream onto your finger.

•    Apply just enough cream to form a thin layer on the affected skin and surrounding areas.

•    Rub in gently. 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 tube and wash your hands.

Even though you will not be using Athlete's Foot 1% w/w Cream 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_N0T_recommended_L

If you accidently swallow Athlete's Foot 1% w/w Cream

Contact your doctor or nearest hospital emergency department if you, or someone else, has swallowed some cream. 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 Athlete's Foot 1 % w/w Cream

If you miss an application, apply the cream as soon as possible then continue your treatment as before.

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

If you stop using Athlete's Foot 1% w/w Cream

Infections may come back if you do not use the cream regularly, or if you stop the treatment too early.

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

4. Possible side effects

Like all medicines, Athlete's Foot 1% w/w Cream can cause side effects, although not everybody gets them.

STOP using the cream 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 a red rash or raised lumps, hives or

blisters.

Other side effects

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 this cream.

Rare: (may affect up to 1 in 1000 people)

•    dry skin, contact dermatitis, eczema.

•    eye irritation.

•    worsening of symptoms.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.oqv.uk/vellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Athlete's Foot 1% w/w Cream

Keep out of the sight and reach of children.

Keep the tube closed and in the carton.

Do not use this medicine after the expiry (EXP) date shown on the box and tube.

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 Athlete's Foot 1% w/w Cream contains

The active ingredient is terbinafine hydrochloride 1% w/w.

The other ingredients are sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60, isopropyl myristate, purified water. (See also end of Section 2 for further information on some of the ingredients).

What Athlete's Foot 1% w/w Cream looks like and contents of the pack

The cream is available in aluminium or laminate tubes of 7 g, 7.5 g, 10 g or 15 g.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

GlaxoSmithKline Consumer Healthcare (UK) Trading Limited,

Brentford, TW8 9GS, UK

This leaflet was revised in January 2016