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LAMISIL CREAM

Active substance(s): TERBINAFINE HYDROCHLORIDE / TERBINAFINE HYDROCHLORIDE / TERBINAFINE HYDROCHLORIDE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LAMISIL® CREAM
(Terbinafine hydrochloride)
Your medicine will be referred to as Lamisil 1% w/w
Cream throughout the remainder of 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. What Lamisil 1% w/w Cream is and what it is used for
2. Before you use Lamisil 1% w/w Cream
3. How to use Lamisil 1% w/w Cream
4. Possible side effects
5. How to store Lamisil 1% w/w Cream
6. Further information.
1.

What Lamisil 1% w/w Cream is and what it is
used for

Lamisil 1% w/w 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 1% w/w Cream

Do NOT use Lamisil 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.
Take special care with Lamisil 1% w/w 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.
Ask your doctor or pharmacist for advice before taking
any medicine.
Driving and using machines
Lamisil 1% w/w Cream is not expected to affect your
ability to drive or operate machinery.
Important information about some of the ingredients
of Lamisil 1% w/w 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 1% w/w Cream

4.

Possible side effects

Adults
Your doctor will decide the right amount of Lamisil 1%
w/w 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 1% w/w Cream, but
may reappear if the cream is not applied regularly or is
stopped too early.

Like all medicines, Lamisil 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.

Directions for use:

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

 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 1% w/w 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 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 Lamisil 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.

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 doctor.
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.

Keep out of the sight and reach of children.
Replace the cap on the tube after use.
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.
If you notice that your cream has become discoloured or
shows any other signs of deterioration, you should seek
the advice of your pharmacist.
6.

If you stop using Lamisil 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.

How to store Lamisil 1% w/w Cream

Further information

What Lamisil Cream contains
 The active ingredient is terbinafine hydrochloride 1%
w/w.
 It also contains 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
It is a white cream and is available in a tube of 30g.

Manufacturer
This product is manufactured by Novartis Pharma
Produktions, GmbH, Wehr, Germany.
It is procured from within the EU and repackaged by the
Product Licence holder: G Pharma Limited, Salford
M50 2PU.
PL NO: 16369/0284

POM

Leaflet revision: 08/02/2016
‘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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