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LAMISIL 1% CREAM

Active substance(s): TERBINAFINE HYDROCHLORIDE

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S180 LEAFLET Lamisil 20170301

PACKAGE LEAFLET: INFORMATION FOR THE USER
®

LAMISIL 1% CREAM
(terbinafine hydrochloride)
The name of your medicine is Lamisil 1% Cream and will be
referred to as Lamisil Cream throughout the following 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.

Important information about some of the ingredients of Lamisil
Cream


For other ingredients see Section 6.
3.

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.

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 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.

In this leaflet:
1.

cetyl alcohol and stearyl alcohol: May cause local skin
reactions (e.g. contact dermatitis).

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.

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.

2.

Children

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.

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

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including those obtained
without a prescription.

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.

Pregnancy and breast-feeding

If you stop using Lamisil Cream

Do not use the cream if you are pregnant or breastfeeding, unless
advised to by your doctor.

Infections may come back if you do not use the cream regularly, or
if you stop the treatment too early.

Ask your doctor or pharmacist for advice before taking any
medicine.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

Driving and using machines

4.

Taking other medicines

Lamisil Cream is not expected to affect your ability to drive or
operate machinery.

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.

6.

FURTHER INFORMATION

What Lamisil Cream contains


Lamisil Cream contains 1% w/w of active ingredient, terbinafine
hydrochloride.



Lamisil 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.

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.

What Lamisil Cream looks like and contents of the pack

These common and uncommon side effects are usually harmless
and you can carry on using the cream.



Lamisil Cream is a white smooth homogenous glossy cream.



Lamisil Cream is available in tubes of 15g

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.

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Limited, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer

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.

This product is manufactured by GLAXOSMITHKLlNE SANTE
GRAND PUBLIC, 100, route de Versailles, CS 80001, 78164 Marly Ie-Roi Cedex, France.
POM

PL: 19488/0180

Leaflet revision date: 01 March 2017
5.

HOW TO STORE LAMISIL CREAM



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the carton or tube
label.



Do not store above 25°C. Replace the cap on the tube after
use.



If your doctor tells you to stop taking the tablets, take any which
you have left back to your pharmacist for safe disposal. Only
keep them if the doctor tells you to.





If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.
Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. These measures will
help to protect the environment.

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
Lamisil® is a registered trademark of Novartis AG, Switzerland.
S180 LEAFLET Lamisil 20170301

S180 LEAFLET Terbinafine 20170301

PACKAGE LEAFLET: INFORMATION FOR THE USER

TERBINAFINE HYDROCHLORIDE 1%CREAM

Important information about some of the ingredients of
Terbinafine Cream


cetyl alcohol and stearyl alcohol: May cause local skin
reactions (e.g. contact dermatitis).

For other ingredients see Section 6.
The name of your medicine is Terbinafine Hydrochloride 1% Cream
and will be referred to as Terbinafine Cream throughout the
following 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.

3.

Adults
Your doctor will decide the right amount of Terbinafine 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 Terbinafine
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.

In this leaflet:
1.

What Terbinafine Cream is and what it is used for

2.

Before you use Terbinafine Cream

3.

How to use Terbinafine Cream

4.

Possible side effects

5.

How to store Terbinafine Cream

6.

Further information.

1.

WHAT TERBINAFINE CREAM IS AND WHAT IT IS USED
FOR

HOW TO USE TERBINAFINE CREAM

Terbinafine 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.

Even though you will not be using Terbinafine 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.

2.

Children

BEFORE YOU USE TERBINAFINE CREAM

Do NOT use Terbinafine 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 Terbinafine 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.

Use in Children is NOT recommended, since there are no data to
support use in this population.
If you accidently swallow Terbinafine 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 Terbinafine Cream

Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including those obtained
without a prescription.

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.

Pregnancy and breast-feeding

If you stop using Terbinafine Cream

Do not use the cream if you are pregnant or breastfeeding, unless
advised to by your doctor.

Infections may come back if you do not use the cream regularly, or
if you stop the treatment too early.

Ask your doctor or pharmacist for advice before taking any
medicine.

If you have any further questions on the use of this product, ask
your doctor or pharmacist.

Driving and using machines

4.

Taking other medicines

Terbinafine Cream is not expected to affect your ability to drive or
operate machinery.

POSSIBLE SIDE EFFECTS

Like all medicines, Terbinafine 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.

6.

What Terbinafine Cream contains


Terbinafine Cream contains 1% w/w of active ingredient,
terbinafine hydrochloride.



Terbinafine 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.

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.

FURTHER INFORMATION

What Terbinafine Cream looks like and contents of the pack


Terbinafine Cream is a white smooth homogenous glossy
cream.



Terbinafine Cream is available in tubes of 15g

Product Licence holder
Procured from within the EU and repackaged by the Product
Licence holder: S&M Medical Limited, Chemilines House,
Alperton Lane, Wembley, HA0 1DX.
Manufacturer
This product is manufactured by GLAXOSMITHKLlNE SANTE
GRAND PUBLIC, 100, route de Versailles, CS 80001, 78164 MarlyIe-Roi Cedex, France.

POM
5.

HOW TO STORE TERBINAFINE CREAM



KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.



Do not use after the expiry date printed on the carton or tube
label.



Do not store above 25°C. Replace the cap on the tube after
use.



If your doctor tells you to stop taking the tablets, take any which
you have left back to your pharmacist for safe disposal. Only
keep them if the doctor tells you to.



If the medicine becomes discoloured or shows any other signs
of deterioration, you should seek the advice of your pharmacist
who will tell you what to do.

PL: 19488/0180

Leaflet revision date: 01 March 2017



Medicines should not be disposed of via wastewater or
household waste. Ask your pharmacist how to dispose of
medicines that are no longer required. These measures will
help to protect the environment.

Blind or partially sighted? Is
this leaflet hard to see or read?
Call 02087997607 to obtain the
leaflet in large print, tape, CD
or Braille.
S180 LEAFLET Terbinafine 20170301

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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