LAMISIL 1% CREAM

Active substance: TERBINAFINE HYDROCHLORIDE

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Order – AWF
Reference
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Pharma code
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Font min. size
Reference MKT
Production site
Reference SITE

AWF 20212 – OTDC 328553
LAMISIL CREAM 30G GB (TUBHA)_310124_PIL
145 x 210 mm – PN-Notice-V11 – Recto/Verso
XXXX
Pantone Reflex Blue U
Helvetica Neue LT Pro
8 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

GSG407191 - JDG - 19.05.2014

Draft A

WARNING: Wrong display / print > switch overprint ON

Recto
11.5 mm

9 mm

11.5 mm

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.

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.
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

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.

127 mm

145 mm

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.

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.

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.
9 mm

1% w/w Cream

Terbinafine hydrochloride

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, includin
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.
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.

210 mm

Pharma code XXXX

72 mm

Order – AWF
Reference
Format
Pharma code
Colour
Font
Font min. size
Reference MKT
Production site
Reference SITE

AWF 20212 – OTDC 328553
LAMISIL CREAM 30G GB (TUBHA)_310124_PIL
145 x 210 mm – PN-Notice-V11 – Recto/Verso
XXXX
Pantone Reflex Blue U
Helvetica Neue LT Pro
8 pts
XXXXXX
NCH Nyon – CH
XXXXXX

Pre-press

GSG407191 - JDG - 19.05.2014

Draft A

WARNING: Wrong display / print > switch overprint ON

Verso
11.5 mm

9 mm

11.5 mm

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
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
or laminate tubes of 15 g or 30 g. Not all pack sizes may
be marketed.
Marketing Authorisation Holder and Manufacturer
Novartis Consumer Health UK Limited,
Camberley, GU15 3YL, UK
® Lamisil is a registered Trade Mark
This leaflet was last revised in May 2014.

127 mm

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.
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 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. How to store Lamisil Cream
Keep out of the reach and sight of children.
Keep the tube closed and in the carton.
Do not use this medicine after the expiry (EXP) date
shown on the box and tube.

GB 310124-XXXXXX
9 mm

145 mm

4. Possible side effects

210 mm

Pharma code XXXX

72 mm

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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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