LAMISIL 1% CREAM

Active substance: TERBINAFINE HYDROCHLORIDE

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Order - AWF
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Production site
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Draft A

OTDC draft 285536 - AWF 16818
LAM CRM GB_305706A_PIL
210 x 145 mm - Recto/Verso - P08 - PN-Notice-V10
XXX
P Reflex Blue U
Helvetica Neue LT Pro
8 pt

Imagelinx - 535598/0/AWK - 02/01/2013

NCH Nyon - CH
GB XXXXXX

WARNING: Wrong display / print > switch overprint ON

RECTO

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.
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 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.

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.

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.
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.

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

Important information about some of the
ingredients of Lamisil Cream

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.

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

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.

Pharma code XXX

Order - AWF
Reference
Format
Pharma code
Colour
Font
Minimum font size
Reference MKT
Production site
Reference SITE
Pre-press

Draft A

OTDC draft 285536 - AWF 16818
LAM CRM GB_305706A_PIL
210 x 145 mm - Recto/Verso - P08 - PN-Notice-V10
XXX
P Reflex Blue U
Helvetica Neue LT Pro
8 pt

Imagelinx - 535598/0/AWK - 02/01/2013

NCH Nyon - CH
GB XXXXXX

WARNING: Wrong display / print > switch overprint ON

VERSO

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.

• 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, itching.
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 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 If any of these side effects get serious, or if you
to try to use the cream at the correct times as forgotten notice any side effect not listed in this leaflet,
please tell your doctor.
applications could risk the infection returning.
If you stop using Lamisil Cream
5. How to store 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 Keep out of the reach and sight of children.
product, ask your doctor or pharmacist.

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).

Do not use this medicine after the expiry (EXP)
date shown on the box and tube.

What Lamisil Cream contains
The active ingredient is terbinafine hydrochloride
1% w/w.
The other ingredients are sodium hydroxide,
benzyl alcohol, sorbitan stearate, cetyl palmitate,
cetyl alcohol, stearyl alcohol, polysorbate 60,
isopropyl myristate, purified water.
(See also end of Section 2 for further information
on some of the ingredients).
What Lamisil Cream looks like and
contents of the pack
The cream is a white cream, available in aluminium
tubes of 15 g or 30 g. Not all pack sizes may be
marketed.
Marketing Authorisation Holder
Novartis Consumer Health UK Limited,
Horsham,
RH12 5AB, UK
Manufacturer
Novartis Consumer Health SA,
CH-1260 Nyon,
Switzerland
® Lamisil is a registered Trade Mark

Medicines should not be disposed of via wastewater
This leaflet was last revised in January 2013.
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
GB 305706 - GB XXXXXX
measures will help to protect the environment.

Pharma code XXX

4. Possible side effects

Keep the tube closed and in the carton.

6. Further information

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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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