LAMISIL 1% CREAM
Active substance(s): TERBINAFINE HYDROCHLORIDE / TERBINAFINE HYDROCHLORIDE / TERBINAFINE HYDROCHLORIDE
LAMISIL 1% CREAM /
TERBINAFINE HYDROCHLORIDE 1% CREAM
This product is available using one of the above names but
will be referred to as Lamisil Cream throughout this leaflet.
Read all of this leaflet carefully before you
start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or
This medicine has been prescribed for you. Do not pass
it on to others. It may harm them, even if their
symptoms are the same as yours.
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:
What Lamisil Cream is and what it is used for
Before you use Lamisil Cream
How to use Lamisil Cream
Possible side effects
How to store Lamisil Cream
Pregnancy and breast-feeding
Do not use the cream if you are pregnant or breast-feeding,
unless advised to by your doctor. Ask your doctor or
pharmacist for advice before taking any medicine.
Driving and using machines
Lamisil Cream is not expected to affect your ability to drive or
2. Before you use Lamisil Cream
Do NOT use Lamisil 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.
Take special care with Lamisil Cream
The cream is for external use only. Do not use on the face.
Avoid contact with 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.
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 Lamisil Cream
cetyl alcohol and stearyl alcohol: May cause local
skin reactions (e.g. contact dermatitis).
For other ingredients see Section 6.
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.
3. How to use Lamisil Cream
If you stop using Lamisil Cream
Important information about some of the
ingredients of Lamisil Cream
Your doctor will decide the right amount of Lamisil Cream for
you to use and will tell you for how long to use your
Apply the cream once or twice a day, for one to two weeks,
but this will depend upon the type and area of infection.
Infections usually appear to improve within a few days of
starting to use Lamisil Cream, but may reappear if the cream
is not applied regularly or is stopped too early.
Directions for use:
1. What Lamisil Cream is and what it is used
Lamisil Cream is used to treat patients with fungal and certain
yeast infections of the skin. It attacks and kills the fungus or
yeast which is causing your infection.
If you accidently swallow Lamisil Cream
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 Lamisil Cream during the
second week for athlete’s foot, 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
Use in children is NOT recommended, since there are no data
to support use in this population.
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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, Lamisil 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
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.
Common: (may affect up to 1 in 10 people): skin peeling,
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 cream.
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 effect not listed in this leaflet, please tell your
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. 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 the sight and reach of children. Your medicine
could harm them.
Replace the cap on the tube after use.
Expiry date: Do not use this product after the expiry date
printed on the carton.
If your doctor decides to stop your treatment, return any
leftover medication to the pharmacist for safe disposal.
If your cream appears to be discoloured or show any other
signs of deterioration, please return to your pharmacist who
will advise you.
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 Cream contains
Lamisil Cream contains terbinafine hydrochloride 1% w/w.
The cream also contains the following inactive ingredients:
sodium hydroxide, benzyl alcohol, sorbitan monostearate,
cetyl palmitate, cetyl alcohol, stearyl alcohol, polysorbate 60,
isopropyl myristate and purified water.
What Lamisil Cream looks like and contents of the
Lamisil Cream is a white, smooth cream in an aluminium tube
with a white screw cap.
Lamisil Cream is available in tubes of 15g or 30g.
Novartis Pharma Productions GmbH, Wehr, Germany.
Procured from within the EU and repackaged by:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
Product Licence holder:
Doncaster Pharmaceuticals Group Ltd., Kirk Sandall,
Doncaster, DN3 1QR.
PL No: 04423/0526
Leaflet revision & issue date: 09.12.15
LAMISIL® is a registered trademark of Novartis AG.
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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.