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LAMISIL 1% CREAM

Active substance: TERBINAFINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER

LAMISIL® 1% CREAM /
TERBINAFINE HYDROCHLORIDE 1% CREAM
(terbinafine hydrochloride)

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 pharmacist.
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:
1.
2.
3.
4.
5.
6.

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
Further information

Children

Use in Children is NOT recommended, since there are no data to
support use in this population.

If you accidentally swallow Lamisil 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 Lamisil 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 Lamisil 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, Lamisil Cream can cause side effects, although not
everybody gets them.

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.

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.

2. Before you use Lamisil Cream

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

are allergic (hypersensitive) to any of the ingredients in the product
(see Section 6)
The cream is NOT recommended for use on children.

Uncommon: (may affect up to 1 in 100 people): skin lesions,

1. What Lamisil Cream is and what it is used for

Do NOT use Lamisil Cream if you:

itching.

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.

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.

Taking other medicines

Reporting of side effects

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 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 operate
machinery.

Important information about some of the ingredients of
Lamisil Cream

cetyl alcohol and stearyl alcohol: May cause local skin reactions
(e.g. contact dermatitis).
For other ingredients see Section 6.

3. How to use Lamisil Cream
Adults

Your doctor will decide the right amount of Lamisil Cream for you to use
and will tell you for how long to use your medication.
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.

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 pack

Directions for use:

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 or pharmacist.
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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.

Manufacturer

Manufactured by: 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

POM

Leaflet revision & issue date: 07.02.14
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.

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