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TERBINAFINE HYDROCHLORIDE 1% W/W CREAM

Active substance(s): TERBINAFINE HYDROCHLORIDE

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Lamisil® 1%w/w Cream

2. Before you use Lamisil Cream

3. How to use Lamisil Cream

(terbinafine hydrochloride)

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.

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.

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.
The name of your medicine is Lamisil 1%w/w
Cream but it will be referred to as Lamisil Cream
throughout this leaflet.
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

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
breast-feeding, 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.

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.

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.

4. Possible side effects

5. How to store Lamisil Cream

Like all medicines, Lamisil Cream can cause side
effects, although not everybody gets them.

Keep out of the sight and reach of children.
Do not store above 25°C.
Do not take your medicine after the expiry date
which is stated on the carton and tube label after
‘Exp’. The expiry date refers to the last day of
that month.

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).

If your cream becomes discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.
Remember if your doctor tells you to stop taking
this medicine, return any unused medicine to your
pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
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
Lamisil Cream contains 1% w/w of active
ingredient, terbinafine hydrochloride.
The other ingredients are: sodium hydroxide,
benzyl alcohol, sorbitan stearate, cetyl palmitate,
cetyl alcohol, stearyl alcohol, polysorbate 60,
isopropyl myristate and purified water.
What Lamisil Cream looks like and contents of
the pack
Lamisil Cream is a white smooth cream in
aluminium tubes with a white screw cap.
Lamisil Cream is available in tubes of 15g.
Manufactured by: Novartis Sante Familiale
S.A.S, 10 rue Louis Bleriot, 92500
Rueil-Malmaison, France.
Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Lamisil® 1%w/w Cream;
PL 18799/2850
Leaflet date: 02.02.2016

POM

Terbinafine hydrochloride
1%w/w Cream

2. Before you use Terbinafine Cream

3. How to use Terbinafine Cream

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.

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.

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.

The name of your medicine is Terbinafine
hydrochloride 1%w/w Cream but it will be
referred to as Terbinafine Cream throughout this
leaflet.
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
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.

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
breast-feeding, unless advised to by your doctor.
Ask your doctor or pharmacist for advice before
taking any medicine.
Driving and using machines
Terbinafine Cream is not expected to affect your
ability to drive or operate machinery.
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.

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 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.

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

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.

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.

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.

If you forget to use Terbinafine 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 any of these side effects get serious, or if
you notice any side effect not listed in this
leaflet, please tell your doctor.

If you stop using Terbinafine 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.

Rare: (may affect up to 1 in 1000 people): eye
irritation, dry skin, contact dermatitis, eczema,
worsening of symptoms.

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.

4. Possible side effects

5. How to store Terbinafine Cream

Like all medicines, Terbinafine Cream can cause
side effects, although not everybody gets them.

Keep out of the sight and reach of children.
Do not store above 25°C.
Do not take your medicine after the expiry date
which is stated on the carton and tube label after
‘Exp’. The expiry date refers to the last day of
that month.
If your cream becomes discoloured or show any
signs of deterioration, seek the advice of your
pharmacist.

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).

Remember if your doctor tells you to stop taking
this medicine, return any unused medicine to your
pharmacist for safe disposal. Only keep this
medicine if your doctor tells you to.
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 Terbinafine Cream contains
Terbinafine Cream contains 1% w/w of active
ingredient, terbinafine hydrochloride.
The other ingredients are: sodium hydroxide,
benzyl alcohol, sorbitan stearate, cetyl palmitate,
cetyl alcohol, stearyl alcohol, polysorbate 60,
isopropyl myristate and purified water.
What Terbinafine Cream looks like and
contents of the pack
Terbinafine Cream is a white smooth cream in
aluminium tubes with a white screw cap.
Terbinafine Cream is available in tubes of 15g.
Manufactured by: Novartis Sante Familiale
S.A.S, 10 rue Louis Bleriot, 92500
Rueil-Malmaison, France.
Procured from within the EU and repackaged
by the Product Licence holder:
B&S Healthcare, Unit 4, Bradfield Road, Ruislip,
Middlesex, HA4 0NU, UK.
Terbinafine hydrochloride 1%w/w Cream;
PL 18799/2850
Leaflet date: 02.02.2016

POM

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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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