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LAMISIL ONCE 1 % CUTANEOUS SOLUTION

Active substance(s): TERBINAFINE HYDROCHLORIDE

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– Recto/Verso

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Read all of this leaflet carefully before you start
using Lamisil Once.
This medicine is available without prescription.
However, you still need to use Lamisil Once
carefully to get the best results from it.
• Keep this leaflet, you may need to read it again.
• Ask a doctor or a pharmacist if you need more
information or advice.
• Contact a doctor or pharmacist if your symptoms
worsen or do not improve within 1 week.
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor or pharmacist.
In this leaflet
1. What Lamisil Once is and what it is used for
2. Before you use Lamisil Once
3. How to use Lamisil Once
4. Possible side effects
5. How to store Lamisil Once
6. Further information

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1. WHAT LAMISIL ONCE IS AND WHAT IT IS USED
FOR
Lamisil Once is a single dose treatment for tinea
pedis (athlete’s foot).

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Lamisil Once works by killing the fungus which
causes tinea pedis (athlete’s foot). When it’s applied
to the feet, it leaves a colourless film that stays on
the skin delivering the active substance into the skin.
How you know that you have tinea pedis
(athlete’s foot)
Tinea pedis (athlete’s foot) appears only on the feet.
It often starts between the toes, but it can also
spread to the soles and sides of the feet.
The most common type of tinea pedis (athlete’s foot)
causes cracking or scaling of the skin. You may also
have mild swelling, blisters, or weeping sores. This
may often be associated with an itching or burning
feeling.
If you are not sure whether your symptoms are
really due to tinea pedis (athlete’s foot), talk to
your doctor or pharmacist, before using Lamisil
Once.

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If you are diabetic you should visit your healthcare professional for regular check ups as diabetes can increase the risk of foot problems.

2. BEFORE YOU USE LAMISIL ONCE
Do not use Lamisil Once
– If you are allergic (hypersensitive) to terbinafine
or any of the other ingredients of this medicine
(listed over the page at the end of section 6).

sure you get rid of the fungus completely: it could
be present in other parts of the feet even if there are
no visible signs of it. When applied to the feet, the
medication dries quickly to a colourless film. The
tube has enough medication to treat both feet.

Take special care with Lamisil Once
– Children and adolescents under 18 are not
to use this medicine, since there is not enough
experience.
– If you suffer from long-term fungal infection
of the soles and heels of the feet with thickened and/or obviously flaky skin do not use
this medicine. Tell your doctor if you think you
may have this condition, because you may need
another medicine.
– Only use this medicine to treat the skin of
your feet. Be careful not to get it on your face, in
your eyes, or on damaged skin (other than at the
treatment site) where it could be irritating.
If it accidentally gets into your eyes, rinse
thoroughly with running water. See your doctor if you are still in any discomfort.
– This medicine should be used with caution in
patients with lesions where alcohol could be
irritating. For example, after sun exposure or in
case of severe skin scaling.
– For external use only. Do not swallow.
– Keep away from naked flames (contains alcohol).

Lamisil Once delivers the active ingredient into the
skin where it lasts for a number of days to kill the
fungus that causes athlete’s foot. To get the best
results, do not wash or splash your feet for 24 hours
after applying it.

Using other medicines
– Do not apply other medicines or treatments
to your feet (including any you have bought
without a prescription) at the same time as
Lamisil Once.
– Tell your doctor or pharmacist if you are
taking or have recently taken any other medicines, including any you have bought without a
prescription.
Pregnancy and breast-feeding
– If you are pregnant or breast-feeding, think you
might be pregnant or are planning to have a baby,
ask your doctor or pharmacist for advice before
taking this medicine.
– Do not use Lamisil Once while breast-feeding,
as terbinafine is excreted in breast milk.
Driving and using machines
– The use of Lamisil Once does not affect the ability to drive and use machines.
3. HOW TO USE LAMISIL ONCE
For adults only. Do not use on patients under 18.
Apply only once. Do not apply it a second time.
You must apply Lamisil Once to both feet, even if
signs are visible only on one foot. This is to make
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When to use
It is best to apply Lamisil Once after a shower or a
bath.
How to use
– This is a single application treatment.
– Wash both feet and dry them carefully.
– Wash and dry your hands.
– Remove the cap from the tube.
– Apply to both feet – use about half the tube for
each foot, as needed to cover skin. Finish one
foot before treating the other.
– Apply with fingers to each foot as shown below.
Spread evenly onto the skin between, under, and
over all toes. Then apply over the sole and sides
of your foot.
– Do not rub or massage it in.

– Treat the other foot in the same way, even if the
skin looks healthy. This is to make sure you get
rid of the fungus completely - it could be on the
other foot even if there are no signs of it.
– Leave it to dry to a film for 1 to 2 minutes, before
wearing your normal footwear.
– Replace the cap on the tube and throw away any
remaining product.
– Do not keep or give any remaining product to
other people.
– Wash your hands with warm soapy water after
the application.
– Do not wash or splash your feet for 24 hours
after applying Lamisil Once. Gently pat dry
your feet after gentle washing.
– Do not apply it a second time.
Lamisil Once will start to kill the fungus immediately. The film that is formed means the active
ingredient penetrates your skin where it continues

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to work for several days. Your skin should start to
improve within a few days, but it may take up to
4 weeks for your skin to heal completely.

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If you have not noticed any signs of improvement within 1 week after applying Lamisil Once,
ask your doctor or pharmacist for advice.
Do not use the product a second time for a particular athlete’s foot episode if it did not work after
the first application.

What if you accidentally swallow some of the
product
Tell your doctor who will advise you what to do.

6. FURTHER INFORMATION

STOP using Lamisil Once 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.
Uncommon: (up to 1 in 100 people): Application
site reactions, which may include skin dryness, skin
irritation or burning sensation, after application, are
uncommon. They are usually mild, temporary and
harmless.
Very rare: (up to 1 in 10,000 people): allergic reactions with rash, itching, blistering of the skin and
hives.

What Lamisil Once contains
Do not use Lamisil Once if you are allergic to
any of these ingredients.
The active substance is terbinafine (as hydrochloride). Each gram of cutaneous solution contains
10 mg terbinafine (as hydrochloride).
The other ingredients are acrylates/ octylacrylamide
copolymer, hyprolose, medium chain triglycerides
and ethanol.
What Lamisil Once looks like and contents of
the pack
Lamisil Once is a clear to slightly cloudy gel-like
solution. It is available in tubes of 4 g.
Marketing Authorisation Holder and
Manufacturer
Novartis Consumer Health
Camberley, GU15 3YL, U.K.
This leaflet was last revised May 2015.

GB 316357 – GB XXXXXX

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By reporting side effects you can help provide more
information on the safety of this medicine.
5. HOW TO STORE LAMISIL ONCE
– Keep out of the sight and reach of children.
– Do not use Lamisil Once after the expiry date
stated on the box and on the tube. The expiry
date refers to the last day of that month.
– Store in the original package to protect it from
light. Do not store above 30 °C.
– 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.

4. POSSIBLE SIDE EFFECTS
Like all medicines, Lamisil Once can cause side
effects, although not everybody gets them.

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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.gov.uk/yellowcard.

To help with treatment
Keep the affected area clean by washing it regularly after the first 24 hours. Dry it carefully without
rubbing. Although the skin may be itchy, try not
to scratch it because this could cause more damage and slow the healing process or spread the
infection.
Use your own towel and clothes and don’t share
them with other people because athlete’s foot can
be passed on easily. Wash your clothes and towels
frequently to protect yourself from re-infection.

What if you accidentally get the product on your
face or in your eyes
Rinse your face or eyes thoroughly with running water. See your doctor if you are still in any
discomfort.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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