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LAMISIL CREAM 30G

Active substance(s): TERBINAFINE HYDROCHLORIDE

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Lamisil® Cream 30g / Terbinafine Hydrochloride 1% Cream
(terbinafine hydrochloride)
Your medicine is available using either 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.

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
In this leaflet:
1) What Lamisil Cream is and what it is used for
2) Before you use Lamisil Cream
3) How to use Lamisil Cream
4) Possible side effects
5) How to store Lamisil Cream
6) Further information

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

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.
Pregnancy and breast-feeding
Do not use the cream if you are pregnant or breastfeeding, unless advised to
by your doctor.

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

If you accidently 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.
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.

5) How to store Lamisil Cream
 Expiry date: Do not use this product after the expiry date printed on the
carton.
 Keep all medicines out of the sight and reach of children.
 Replace the cap on the tube after use.
 If your doctor decides to stop your treatment, return any leftover medication
to the pharmacist for safe disposal. Only keep your medicine if you doctor
tells you to.
 If the cream becomes discoloured or shows any other signs of deterioration,
consult your doctor or pharmacist.
 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
It contains the active ingredient Terbinafine hydrochloride 1% w/w in a white
cream base.
Lamisil Cream also contains the following: 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 the contents of the pack
It is white, smooth or almost glossy cream in a metal tamper-evident tube in a
printed carton.

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

Lamisil Cream is available as tubes of 30g.

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.

PL 10383/0304

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 doctor.
Reporting 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.

POM

Who makes and repackages your medicine:
Your medicine is manufactured by Novartis Farmceutica S.A, Gran Via de les
Corts Catalanes, 764 08013 Barcelona, Spain Procured from within the EU
and repackaged by the Product Licence holder: Primecrown Ltd, 4/5 Northolt
Trading Estate, Northolt, Middlesex UB5 5QS.
Leaflet date: 18.08.2015
Lamisil is a registered trademark of Novartis AG, Basel, Switzerland.

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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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